Head of HSE, Horn of Africa

Azure Cloud Administrator

Customer Quality Engineer

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

  Principal R&D/Product DVL Engineer - Remote

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

Role Description: <ul><li>To ensure that work processes are implemented as designed and comply with established policies, processes, and procedures.</li><li>Ensure compliance with both standard and regulatory requirements as relevant for all entities in the Horn of Africa.</li></ul> Responsibilities: <ul><li>Play a lead role in promoting and developing safe work culture that embraces zero harm through health, safety and environmental awareness by stimulating active involvement and interaction at all organizational levels.</li><li>Maintain the safety standards to be in compliance with company HSE policies and countries legislations.</li><li>Collate and analyse data for trend analysis &amp; statistics at regular intervals to achieve continual improvement on all aspects of HSE and related training of personnel.</li><li>Involve in high level investigation &amp; Investigate accidents effectively and determine root cause analysis along with project clients.</li><li>Identify and act upon opportunities for improvement to safety related matters.</li><li>Liaise with project managers / client / stakeholders as deemed necessary for discussion on project safety matters and resolve issues.</li><li>Drive and support the business in implementing HSE standards for contracts and suppliers through the HSE team in each business unit.</li><li>Provide advice and support to line management for conducting risk assessments and ensuring that operational risks are proactively and appropriately managed.</li><li>Overview and ensure proper adherence to ICAM procedure for incident investigations and implement effective control measures for closure of the gaps identified to prevent recurrence.</li><li>Evaluate and ensure emergency response preparedness through regular emergency mock drills and upkeep of the emergency response procedures.</li></ul> Requirements: <ul><li>Post Graduate qualification in Safety with at least 15 yrs work experience in the field of Safety Management and Training; OR</li><li>Graduate in any field with Diploma in Industrial Safety with at least 10 yrs work experience in Safety Management and Training; OR</li><li>Knowledge of ISO and other International Standards related to Quality, Environment and Occupational Health &amp; Safety</li><li>Lead Auditor certification in Quality Management System</li><li>Computer literate in Microsoft Office applications</li><li>Very good communication in English 	</li></ul>

Responsibilities: <ul><li>Provision, configure, and manage core Azure resources, such as virtual machines, storage accounts, and networks.</li><li>Implement and maintain Azure Active Directory (AAD) for identity and access management.</li><li>Configure and enforce role-based access control (RBAC), policies, and security protocols.</li><li>Ensure the integrity of data through encryption and secure networking, including firewalls and network security groups.</li><li>Manage backup strategies using Azure Backup, ensuring system reliability and minimal downtime.</li><li>Design and implement secure virtual networks, including subnets, VPNs, and ExpressRoute for hybrid cloud environments.</li></ul> Requirements: <ul><li>Has overall 8+ years of IT experience in Microsoft Technologies Microsoft Azure, .Net and Azure DevOps.</li><li>Experience in design, architect and implementing the Azure infra as a new data center, migration of workloads, providing Backup &amp; Restore and DR solutions</li><li>Strong hands on experience on Azure Cloud Administration.</li><li>Excellent Technical, Analytical and Problem-Solving skills and ability to get on well with people</li><li>Involve in RFP and provide technical solutions for Azure related, Bill of materials and effort estimates</li><li>Strong knowledge on PowerShell scripts and ARM Templates</li><li>	Public Sector experience and GCC experience is must.</li></ul> Working Experience: <ul><li>Experience in design, architect and implementing the Azure infra as a new data center, migration of workloads, providing Backup &amp; Restore and DR solutions</li><li>Strong hands on experience on Azure Cloud Administration.</li><li>Excellent Technical, Analytical and Problem-Solving skills and ability to get on well with people</li><li>Involve in RFP and provide technical solutions for Azure related, Bill of materials and effort estimates</li><li>Strong knowledge on PowerShell scripts and ARM Templates</li><li>Public Sector experience and GCC experience is must.</li></ul>

Responsibilities: <ul><li>Quality point of contact for assigned Southeast Asia customer accounts.</li><li>Provide the Voice of the Customer feedback to product management, product engineering and manufacturing locations for characteristics that can become quality or application risks to the customer.</li><li>Manages Quality / Reliability interactions with the customer, including regular communication and escalations.&nbsp;</li><li>Provides technical support in evaluating products from a quality and reliability standpoint.</li><li>Leads cross-functional problem-solving teams to investigate quality issues and minimize customer impact, Company PPM, cost of poor quality and drive timely resolution.</li><li>nfluences without authority in efforts to achieve 5D/8D response time within 10 business days or less.&nbsp;</li><li>Responsible for coordinating and ensuring completion of customer quality requested activities across design and manufacturing. This includes coordinating globally for all sites, factories, and associated teams within company.&nbsp;</li><li>Carries out the customer quality improvement strategy.</li><li>Ensures compliance to company quality policies and procedures related to customer requirements.</li><li>Partners closely with sales, engineering, and operations to ensure organizational alignment regarding setting targets and achieving quality objectives for our customers.</li><li>Partners with engineering and sales to establish trust with our customers by sharing our DND strategic quality roadmap as well as resolving problems in a timely manner.</li><li>Regularly conducts reviews with key customers regarding DNDs quality &amp; delivery performance.</li><li>Drives systemic corrective action and continual improvement for customers through training and implementation and use an array of quality improvement tools.</li><li>Regularly reports to management on the overall performance and effectiveness of the assigned strategic customer account.</li><li>Manage quality issues or inquiries for parts in assigned Global Product Lines. The parts may be made at a company facility or at a sub-tier supplier.&nbsp;</li><li>Supports the MRB team functions for disposition of non-conforming products.</li><li>Visit local customers and travel within Southeast Asia to customer locations to review company product and application as it is being used by the customer and to foster productive working relationships.</li><li>Conduct audits at manufacturing sites and attend to customer audits.&nbsp;</li><li>Work with DC, Planner, Sales &amp; CCP on block stock &amp; RMA return.</li><li>Coordinate onsite sorting at customer site with Sales, Planner &amp; CCP.</li><li>Coordinate RMA request &amp; return with manufacturing.</li></ul> Requirements: <ul><li>Bachelor Degree in Engineering with technical focus.</li><li>5+ years minimum quality assurance experience working in a global capacity.</li><li>Preferred customer quality experience in the electronics industry.</li><li>Demonstrated ability to lead teams, forge strong internal relationships, and drive transformation globally.</li><li>Knowledge and application of quality system regulations (ISO 9000, 14000 and 18000).</li><li>Experienced in the use of Lean, Six Sigma, Kaizen, 8D and other advanced statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), and Process Capability (CpK) techniques.</li><li>Possesses strong leadership skills and executive level presence.</li><li>Self-motivated, efficient, ability to work with little or no supervision, and committed to a team approach.</li><li>Strong interpersonal, organization, and project management skills.</li><li>Ability to prioritize responsibilities in a fast-paced work environment.</li><li>May require travel to customers and other company locations, including overnight and multi-day trips.</li><li>Experience in core processes such as stamping, molding, plating and assembly preferred.</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Role Description: <ul><li>The Data and Devices Business Unit is looking for a Principal R&amp;D Product Development Engineer (PDE) to design and develop socket, high-speed connector, and cable assembly solutions that are used inside switches, servers, and storage for data communication.</li><li>In this role, you will be responsible for establishing a clear vision and strategy driving the design and documentation of new products, from market definition through production and release.</li><li>You will conceive original ideas for new products/solutions and develop them into practical and economical models.</li><li>You will determine specifications, perform engineering analysis, make preliminary sketches and designs, and coordinate support operations (such as fabrication of engineering samples and testing).</li><li>Interaction with customers, vendors, marketing and sales personnel, and other engineering areas during the pre-production stages of new products is also an important part of this role.</li></ul> Responsibilities: <ul><li>Responsible for product development of socket, high-speed connector, and cable assembly solutions from market definition through production and release:</li><li>Work closely with the customer and our client sales/SA/FAE/PM in getting the right and clear VOC (voice of customer) and convert to a our client design conceptualization and preliminary product specification.</li><li>Conceive concepts and perform feasibility studies</li><li>Run mechanical and thermal simulations.</li><li>Make the engineering evaluation/proposal to the customer.</li><li>Create the detailed design including 2D/3D drawings and perform DFMEA/tolerance analysis.</li><li>Build prototype samples and perform validation.</li><li>Complete product qualification and finalize product specification.</li><li>Provide technical support to the Operations team including Quality and Production for efficiency improvement and safe launch.</li><li>Resolve product-related issues to closure and manage the ECN/PCN (Engineering Change Notification/ Product Change Notification).</li><li>Build a deep understanding of the market and customer needs by fostering a connection between the business engineering teams and the customer engineering teams.</li><li>Maintain a system-level understanding of the customer application and the product design/concept necessary for providing a solution to the customers’ expectations.</li><li>Follow the LEANPD Project Process to support the project team from the product development engineering (PDE) perspective to complete the new product development project on time, quality, and budget. Drive the development and release of the product, scale-up through stage-gate reviews, ensuring milestone commitments are maintained.</li><li>Provide technical support to customers, sales, PM, and plant teams.</li><li>Conduct necessary DFMEA, tests, engineering analysis, troubleshooting, and verification.</li><li>Work with global manufacturing resources, procurement, and outside suppliers to meet all our client technical, quality, and cost objectives.</li><li>Execute technical documentation to fully detail design drawings and requirements, engineering, and product change notices, and design history files.</li></ul> Requirements: <ul><li>Bachelor’s degree, preferably in Engineering, Supply Chain, or Business</li><li>12+ years’ experience working in a manufacturing organization, including a minimum 5+ years management experience, with proven success in driving transformational change and continuous improvement while simplifying processes and increasing production</li><li>General project leadership experience</li><li>General knowledge of financial terms and concepts</li><li>Lean and/or Six Sigma experience</li><li>Experience working with multiple customers and suppliers in a low volume, high mix industry</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR).</li><li>Applicants must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.</li></ul>

Responsibilities: <ul><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.&nbsp;</li><li>Implement quality planning and controls for prototype and/or sample builds and manage build records and documents.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during developing stage.&nbsp;</li><li>Involve and drive for design verification before design freeze and product qualification testing before Gate5 of project.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool</li></ul> Approval Report (CTAR): <ul><li>Implement quality controls and documentation needed for production shop floor.</li><li>Monitor process capability and oversee ongoing corrective actions as required.</li><li>Review and approve the measurement and cosmetic inspection.</li><li>Support the customer and quality system audit as required</li></ul> Talent Development &amp; Leadership: <ul><li>Support a culture of engagement and performance in alignment with TE’s core values&nbsp;</li><li>Provide timely, thoughtful feedback to support your team’s growth and development</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>At least Bachelor degree in Electrical or Mechanical Engineering or related field</li><li>Quality control experience in cable assembly / connector / Socket or relevant industry.</li><li>Good written and oral English communication.</li><li>Understand ISO9001 quality system.</li><li>Be good at SPC, FMEA, MSA, and 7-QC tools.</li><li>Experienced in Statistical Process control techniques.&nbsp;</li><li>Understand GD&amp;T definition and requirements.</li><li>Be good at APQP procedure and requirements.</li><li>Be familiar with EIA-364 test procedures.</li><li>Ability to foster teamwork and internal and external relationships.</li><li>Excellent organizational habits and priority management</li><li>Customer focused with a commitment to quality.</li><li>Internal / External Auditor</li><li>Six Sigma (Black/Green Belt)</li><li>Design of Experiments</li><li>Up level Communication</li><li>Strategic Planning</li><li>Skilled in using software (Mini Tab / JMP)</li><li>Quality Leader</li></ul>

Responsibilities: <ul><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.&nbsp;</li><li>Implement quality planning and controls for prototype and/or sample builds and manage build records and documents.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during developing stage.&nbsp;</li><li>Involve and drive for design verification before design freeze and product qualification testing before Gate5 of project.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool</li><li>Approval Report (CTAR).&nbsp;</li><li>Implement quality controls and documentation needed for production shop floor.</li><li>Monitor process capability and oversee ongoing corrective actions as required.</li><li>Review and approve the measurement and cosmetic inspection.</li><li>Support the customer and quality system audit as required</li></ul> Talent Development &amp; Leadership: <ul><li>Support a culture of engagement and performance in alignment with TE’s core values</li><li>Provide timely, thoughtful feedback to support your team’s growth and development</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>At least Bachelor degree in Electrical or Mechanical Engineering or related field</li><li>Quality control experience in cable assembly / connector / Socket or relevant industry.</li><li>Good written and oral English communication.</li><li>Understand ISO9001 quality system.</li><li>Be good at SPC, FMEA, MSA, and 7-QC tools.</li><li>Experienced in Statistical Process control techniques.&nbsp;</li><li>Understand Model Based Dimensioning (MBD) and requirements</li><li>Understand GD&amp;T definition and requirements.</li><li>Be good at APQP procedure and requirements.</li><li>Be familiar with EIA-364 test procedures.</li><li>Ability to foster teamwork and internal and external relationships.</li><li>Excellent organizational habits and priority management</li><li>Customer focused with a commitment to quality.</li><li>Internal / External Auditor</li><li>Six Sigma (preferred Black Belt)</li><li>Design of Experiments</li><li>Up level Communication</li><li>Strategic Planning</li><li>Skilled in using software (Mini Tab / JMP)</li><li>Quality Leader</li></ul>

Responsibilities: <ul><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li><li>Responsible to get the necessary documents which are going to be useful for registration purpose.</li><li>Usually, this registration application is done online, and you need to constantly keep a follow up with the regulatory team.</li><li>Responsible to liaise with the authority daily based on the requirements pertaining to document for the smooth transition with the regulator and submit regularly to the regulating authority to get the registration executed in a timely manner.</li><li>Front lining the entire process with respect to coordination with Originator, regulatory authority and in need be travel to Delhi for meetings.</li><li>The company has tied up with an agency to make sure there are no gaps and you will be responsible to liaise with the Agency who closely work with the government authority to satisfy the documentation requirements.</li><li>You will be also responsible to regularly interact and funnel the requirements with the agencies and the regulatory authorities.</li><li>Ensure all products comply with applicable laws, regulations, and standards as per Indian laws</li><li>Stay updated on regulatory changes and assess their impact on the companys products or processes.</li><li>Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.</li><li>To do necessary follow-ups with regulatory agencies to get approval of the medical devices/pharmaceutical products.</li><li>Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.</li><li>Lead or assist in regulatory audits conducted by agencies or certification bodies.</li><li>Identify and mitigate regulatory risks that could impact product approvals or market access.</li><li>Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.</li><li>Conduct training sessions for cross-functional teams on regulatory requirements and best practices.</li></ul> Requirements: ﻿Skills and Qualifications <ul><li>Bachelors degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.</li><li>Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.</li><li>Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).</li><li>Excellent project management and organizational skills.</li><li>Ability to analyze and interpret complex regulations.</li><li>Proficient in regulatory writing and submission tools.</li><li>Strong communication and interpersonal skills.</li><li>Ability to manage multiple projects and meet deadlines.</li></ul> Experience <ul><li>7–8 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals.</li><li>Experience in handling registration of Medical Devices and getting approval.</li></ul>

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87 access control Jobs found

Head of HSE, Horn of Africa

Azure Cloud Administrator

Customer Quality Engineer

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Principal R&D/Product DVL Engineer - Remote

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

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87 access control Jobs found

Head of HSE, Horn of Africa

Azure Cloud Administrator

Customer Quality Engineer

Operation Supervisor

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Principal R&D/Product DVL Engineer - Remote

Advanced Quality Engineer

Advanced Quality Engineer Manager

Regulatory Affairs Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.