AVP Delivery Infrastructure

Regulatory Affairs Professional (Product Regulatory Expert)

Product Specialist - Ultrasound Devices ( Sales)

Ecom Manager

Business Development Lead (Global Role)

Regulatory Affairs Manager

OT Project Manager_NOF

ASC Civil Structural Design Engineer

National Sales Manager - Devices

Chemical Engineer – Relief Systems Process Safety

Responsibilities:Manage and mentor a team of network engineers to provide daily operational network technical supportManage network-related projects from initiation to implementation as well as getting project signoffs from Customer’s stakeholders for project closureManage Customer’s stakeholders (Tech Ops, Enterprise Architects, Cybersecurity, PMO, Procurement, Legal), internal stakeholders and external vendors and/or service providersEnsure full compliance with SLAs, IT policies and audit requirements, and provide support to all audit activitiesProvide cross-functional support to other business units whenever a need arisesOversee all aspects of network service delivery including but not limited to maintenance of network design, architecture and security, network device/service availability, configuration, capacity, patch management and problem management, technology refresh etc.Manage the following technologies:Cisco routing and switchingCisco SD-WAN and Cisco ISEZscalerFirewall – Palo AltoCisco WirelessAct as escalation point and lead on any network-related incident triage call together with internal stakeholders, customers, and external vendors/service providersParticipate in planning, design, preparation, and network implementation for supporting Customer’s major eventsWork closely with third party vendor, Customer’s Business Owner, Technology Directors, Enterprise Architects to provide technical support in Customer’s POC initiatives.Requirements:Degree holder13 years of experience in managing network operations including stakeholder managementExperience in previous roles of similar capacity in a client-servicing environment, handling enterprise network routing, switching and wireless technologyProficient in Cisco SD-WAN/ISEProficient in Palo Alto

Responsibilities:Work closely with Quality Assurance to obtain regulatory documentation required to maintain drug master files (DMFs)Prepare and submit annual updates and amendments for DMFs to global regulatory agencies in accordance with the regulatory agencies’ guidelines.Engage with and monitor external consultants utilized for submissions.Track regulatory submissions to ensure timely filings in accordance with regional regulatory requirements.Maintain regulatory records, including archiving of regulatory submissions.Work closely with Product Stewards, Quality and project teams to outline regulatory requirements, costs, and timelines for new DMFs required to support new or expanding products.Acquire in-depth knowledge of company current and developing portfolio of products used in the regulated markets mentioned above in order to answer compliance related questions from internal partners,external parties, and add value to existing and new customer engagement discussions.Maintain awareness of global regulatory legislation and its impact on company products and businessProvide appropriate information to promote the safe use of company products throughout their entire life-cycle to:External Stakeholders – including customers, distributors, and industry partnersInternal Stakeholders - including Product Stewards and SMEs, manufacturing, technology, product management, and sales & marketing personnelDevelop/maintain a sound awareness of global trends in pharmaceutical regulations.Prepare responses for customer inquiries.Execute reviews/approvals for new product reg tox and commercialization requests related to applications in regulated markets.Assist with special projects related to Product Stewardship & Regulatory Affairs, as needed.Learn other areas within the Food, Drug, Device, Cosmetic (FDDC) Regulations to provide support to the FDDC team.Requirements:Minimum of Bachelor’s degree (or higher) required.2 – 5+ years of experience in a regulatory affairs role.

Job Description / Responsibilities:- Promoting the products and generating business- Achieving assigned area and brand-wise sales targets- Conducting activities and programs as per company strategy—Product demonstrations, symposiums, CMEs, etc. to generate revenues- Maintaining excellent relationships with all leading customers in the area- Promoting, positioning, and selling existing brands of Wellesta- Ensuring full placement of products in the entire market- Increasing market reach and visibility- Conducting doctors' meets- Organizing educational training programs and other marketing activities- Obtaining necessary government approvals for product demonstrations- Following up with customers to resolve any issues and ensure satisfaction Desired Profile of the Candidate- Hard worker with good market knowledge- Self-starter with initiative and result-oriented- Positive attitude- Good communication & documentation skills- Good analytical & interpersonal skills- Committed & ambitious, ready to take challenging responsibilities Minimum Experience:- Exposure to sales & marketing of ultrasound devices- Minimum 3 years in the pharma industry, with at least 1 year in medical devices sales Compensation Offered:- In line with industry standards, flexible depending on specific skill sets and experiences of the candidate. Product: Ultrasound Machine Important: Must be aware of PCPNDT law

Responsibilities:You will develop plan, KPI and goals for the account and implement Go to Market strategy with cross functional teams (commercial managers, brand managers, supply chain,) You will be responsible for business and market development and scope out opportunities for growth and key initiatives to leverage category growth and market share on the platforms.You will manage promotions along with brands - make brands partners in customer communication. Creates an annual business plan / e-trade marketing plan : taking into account levers of growth to achieve brand results (sell-in, sell-out, market shares) and the profitability of brands within the account.You will innovate and activate key launches, campaigns and collaborations with marketing and digital for impactful brand presence leading to business. You will ensure right presence on brands across top SKUs discoverability, build customer experience through brand stores and product page details and compelling reasons to drive purchase. Ensure Medical UX execution and adherence on platform. Ensure correct elements across platforms like Medical Labelling, Dermo Category, HCP services etc.You will do market intelligence and competitive landscape mapping thereby identifying new e-commerce trends and opportunities.You will drive efficiency and effectiveness across supply chain and customer care through accuracy in demand forecasting and setting supply chain and logistics processes.Analyse and interpret Ecommerce partner’s sales report to identify strengths, weaknesses and business opportunities.Able to get more data insights from platforms to fuel it in the business strategyRequirements:3-5 Years of experience ideally in e-commerce environments. A confident and articulate communicator capable of inspiring strong collaboration within an organization.Ability to analyse data to gather insights and find opportunities.Builds and develops a trust relationship with e-retailers.Ability to manage simultaneous projects and meet deadlines.Business results oriented: ability to perform, to budget and manage forecast.Proactive, positive, and innovative mind.

Job Summary:We are seeking a dynamic and results-driven Business Development Lead with a minimum of 2 to 3 years of experience to join our team. The ideal candidate will have a background in healthcare (Pharma or Devices), This role involves significant exposure to in-licensing and out-licensing and will encompass both global responsibilities and a strong emphasis on marketing over sales. The role is pivotal in driving revenue growth, managing client relationships, and supporting devices, formulations, and OTC products, with a great emphasis on niche and unique product opportunities.Responsibilities:Business Development:Identify and pursue new business opportunities in the healthcare (Devices) sectors through market research, networking, and cold outreach.Develop and implement strategic business development plans to achieve company goals and targets on a global scale.Conduct competitive analysis and market research to stay abreast of industry trends and opportunities, particularly in the devices sector.Client Relationship Management:Build and maintain strong relationships with key clients and partners globally.Understand client needs and provide tailored solutions to meet their requirements.Ensure high levels of client satisfaction and retention.Sales Drive the sales process from lead generation to closing deals, with a significant focus on marketing initiatives.Prepare and deliver compelling presentations and proposals to potential clients.Negotiate contracts and agreements, with exposure to in-licensing and out-licensing.Collaboration and Communication:Work closely with the marketing, product, and operations, medical and regulatory teams to align business development efforts with overall company strategy.Provide regular updates and reports on business development activities and outcomes.Represent the company at industry events, conferences, and trade shows.Marketing Focus:Develop and execute marketing strategies to promote products and services, with a heavier weightage on marketing activities compared to sales.Create and manage marketing campaigns to drive brand awareness and generate leads.Requirements:MBA with a focus on healthcare and commercial operations.2 to 3 years of experience in business development, sales, or a related role in the healthcare or pharmaceutical industry.Proven track record of pursuing sales targets and driving revenue growth.Excellent communication, negotiation, and interpersonal skills.Strong analytical and strategic thinking abilities.Experience in in-licensing and out-licensing is highly desirable.Ability to work independently and as part of a team.Proficiency in Microsoft Office Suite and CRM software.Preferred Qualifications:Experience in supporting devices, formulations, and OTC products, with a great emphasis on devices.

Responsibilities:Key Functions:Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products.Responsible to maintain local SOPs and ensure compliance with regulations are met.Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.Provide support to commercial team from regulatory perspectives.Poison License Holder, company pharmacist.Primary contact with Regulatory Authority Department in the country.Regulatory :Product scope includes new molecules, generics, biosimilars, medical devices, diagnostics and OTC.Lead local regulatory work for pharma division including new product/ device registrations, variations and renewals.Conduct regulatory related submission/ correspondence with respective local health authorities (National Pharmaceutical Regulatory Agency NPRA and Medical Device Authority MDA).Develop registration strategies, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives. Review, analyze and coordinate data for new product submissions, line extensions according to priorities. Ensure up-to-date product registration, variation, line extension and other related law & regulations knowledge.Ensure that the content complies with government regulations prior to submission to Regulatory Authority.Maintain an awareness of country’s regulatory legislation and assess its impact on company’s business.Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.Maintenance of regulatory related database and licences such as product technical files, product complaints and adverse drug reaction records, import and poison A licences, etc.Local SOPs and Policies :Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with NPRA and MDA requirements.Lead applicable regulations and standards including cGMP and Safety; Compliance topics and quality systems such as GDP, Change Control, Data Integrity, auditing, and Complaint Handling. Support Marketing Activities :Conduct strategy meetings with commercial team to discuss product pipelines and registration plans.Provide management with a monthly registration status.Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.Pharmacovigilance (PV) and Quality Assurance (QA) Support :Lead local pharmacovigilance system in line with local regulatory requirements. Drive maintenance and preparation of local quality management system and internal audit in compliance to local regulatory requirements,Requirements:Qualifications :Bachelor’s degree in pharmacy.Registered pharmacist recognized by MOH Malaysia.Experience in regulatory affairs in a pharmaceutical or medical device company.Familiar with local regulatory bodies such as NPRA and MDA.Strong initiative and ability to take lead on projects.

Responsibilities:Project Management:Oversight of all small package and Mail Innovation project scheduling.Collaborates with region project managers to approve or request submission facility revisions.Participates in corporate project bid reviews.Conducts weekly staffing meeting to ensure proper integrator assignments.Impacted groups include Integrations, Data Acquisitions, Electrical, PLC/HMI, and Reporting.Manages deployment schedules and resources to meet service level needs and to deliver results. Leads product assessments, planning, design, and deployments to evaluate risk. Acts as a liaison to I.S. partners to manage release schedules and to communicate activities and progress. Manages post-release reviews to measure results. Verifies implementations to ensure release processes and procedures are applied effectivelyContinuously maintains current item costs and estimate calculations.Completes 35 to 45 estimates per year as requested by the Systems Design Group.Impacted groups include Integrations, Data Acquisitions, PLC/HMI, and Reporting.Hardware Procurement:Determines hardware requirements for all projects (from servers to cables).Coordinates with PPD to procure required hardware for all projects.Collaborates weekly on PPD Region/District status meetings.Reviews procurement process with site Project Managers.Impacted groups include Integrations, Data Acquisitions, PLC/HMI, and Reporting.Cost Tracking:Oversees OT project cost tracking.Provides cost detail as requested to site Project Managers.Impacted groups include Integrations, Data Acquisitions, and Reporting.Facility Data Transitions:Ensures site HST1s (Server Provisioning) are completed.Conducts facility LAN review meetings as needed (Flat/Layer 3).Oversees project site IP address creation.Reviews/approves project site IP address additions and corrections.Impacted groups include Integrations, Data Acquisitions, PLC/HMI, and ReportingProject Forecasting:Performs discovery for future projects from sources including corporate project bid reviews, estimate requests, and individual contacts.Documents and maintains findings in detail.Utilizes findings to aid in Data Acquisitions contracts and annual DSC staffing calculations.Manages, plans, and administers installation and decommissioning activities to expedite initiatives. Drafts and maintains policy, standards, and procedures to document processes. Manages team training to optimize resources. - Manages and maintains customer relationships to track and measure service levels. Collaborates with I.S. technology providers and vendors to ensure services are consistent and meet expectations. Supports long-term planning to ensure future service level expectations are met Project IntegrationsContinuously oversees all level 3 project integrations.Acts as a liaison between the DSC and the Region Project Managers.Oversees weekly Level 3 project review meeting with East and West Regions.Impacted groups include Integrations, Data Acquisitions, Electrical, PLC/HMI, and Reporting.IP Re-Addressing:Acts as a liaison between the DSC and GNS for GNS Operational Technology re-IP projects.Oversees Operational Technology device discovery by site.Conducts meetings with impacted Operational Technology groups as needed.Impacted groups include Integrations, Data Acquisitions, Electrical, PLC/HMI, and Reporting.Other Projects:Manages project life cycles (i.e., project scope, resources, schedule, budget, initiation, start-up, design, building, and deployment) to see projects from beginning to end. Forwards project documents to stakeholders to obtain sign-off, agreement on project costs, and needed resources. Creates, prepares, and maintains project plans to estimate resources, plan schedules, define goals, establish metrics, assess risks, and develop cost plans and to provide stakeholder reports. Ensures affected functions and groups are identified to negotiate changes and ownership of processes and to manage project impact. Provides status communications for senior management on issues, concerns, and risks to recommend solutions and to ensure products meet customers' needs. Monitors assigned resources formally (e.g., status meetings, etc.) and informally to continuously manage team productivity, project timelines, and deliverables. Balances multiple projects and deployment schedules to meet stakeholder goals and expectations. Determines decisions regarding tools, methods, and approaches to meet project goals. Manages the change control procedure to ensure project deliverables are formally reviewed, completed within planned cost and timeframe, and closed.Manages and Develops Others:Manages resources and people processes (e.g., career Development, training, staffing, etc.) to ensure the day-to-day administration of processes and formal procedures. Identifies individual and team skill gaps and developmental opportunities (e.g., training, special assignments, conferences, projects, etc.) to facilitate individual and team development. Ensures that direct and indirect reports have documented career goals and detailed plans for achieving these goals to develop them personally and professionally. Conducts frequent performance evaluations in a consistent, fair, and objective manner to facilitate open communication and encourage continuous performance improvement. Holds others accountable to established performance levels to achieve individual and group goals. Resolves individual and group performance issues in accordance with company policies and procedures in a timely manner to motivate and foster teamwork. Coaches others and provides on-going feedback and support to improve performance. Identifies opportunities to involve others in new and challenging work assignments and/or rotations that advance the skills and capabilities of individuals and the organization. Makes salary recommendations to reward employee performanceRequirements:Bachelor’s Degree: EngineeringNeed to have Team handling and Project Management experience.Preferred Linux hands on experience.

Responsibilities:You will be required to perform the following:Produce a full-fledged engineering design package that includes all required documents/drawings, for all onshore and offshore oil and gas facilities throughout the Northern Area. The design work requires a thorough knowledge and familiarity with the company and industry standards.Perform structural design including production of construction documents related to onshore/offshore hydrocarbon facilities.Identify design requirements and prepare necessary design calculations using hand calculations and software such as STAADPro V8i or equivalent finite element analysis software.Perform engineering assessments for the repair of deteriorated concrete, prepare technical reports and verify ‘As-Built’ record drawings for accuracy.Prepare layout plans and structural engineering details for development by draftsmen and designers.Prepare detailed scope of work, material take-offs and cost estimates as part of the construction documents.Perform field activities such as site surveys and record existing field conditions, take and verify measurements within project area.Participate in projects walkthroughs and provide reports of findings.Provide mentoring and transfer knowledge, skills and experience to entry-level engineers and designers.Requirements:The candidate shall hold a Bachelor degree in Civil Engineering. A Master’s degree in Structural Engineering is preferred. You must have interpersonal skills including ability to communicate and contribute positively to the project design team.A minimum of ten-year experience in structural engineering design of reinforced concrete, steel, masonry and wood structures using US Design Codes and Standards. Extensive experience using industry codes such as ASCE, ACI, AISC, UBC is required. In addition, the candidate shall have basic architectural knowledge, enough to serve basic building re-designs/renovations/remodeling.You should have expertise in using STAADPro software. In addition, you should have working knowledge of Microstation or other drafting software. It is required to have a strong technical and engineering design skills in a design office environment. A Professional Engineering Registration/License from the US/CA is a plus.The candidate must be physically fit to visit offshore sites, which requires going by chopper or boat. There shall be no physical/medical restrictions.

Responsibilities:To monitor implementation of the sales strategy and execution for achievement of targets in the assigned geography in an ethical manner.To Budget, Plan & Modify the working of each Team Member in terms of Sales Execution Strategies in such a way that maximum ROI is achieved.To be able to launch and establish new products successfully.To be able to work with the philosophy of profit maximization and cost minimization with resource optimization.To develop the capabilities of the reportees by ongoing coaching and regular performance reviewsTo be able to delegate work to a team appropriately and monitor their performance regularly.To create new customers, retain them and do effective customer management.To spot talent and develop High Performers in the team.To successfully drive new initiatives by partnering with relevant internal & external customers Educational training programs and other marketing activities.Obtaining necessary government approvals for product demonstrationsFollow up with customers to resolve any issues and ensure satisfactionRequirements:Minimum 10 -12 yrs. in Medical Devices IndustryMinimum 5 yrs. in Supervisory/ people management position at Zonal / National LevelMultiple Zone working experience.Exposure to sales & marketing of Ultrasound Devices would be an added advantage.Good connection in Hospitals.Proven track record

Responsibilities:Evaluate, design and document vessels for potential over pressure and vacuum scenarios (new & existing) – relief device (PSV, RD, conservation vents) relief load calculation, inlet and outlet line sizing, size selection and datasheet preparation, and relief/flare load summary preparation. Design, model, document, and communicate requirements for pressure/vacuum relief devices and effluent handling.Understanding of mechanical design conditions and to utilize the process safety information in designing relief system to safeguard piping and equipment.Understanding of HAZOP, PHA report, SIL studies - provide relief system input from these reports. Design of overpressure protection for gas/vapor filled systems using Depressurization concept. Material & Energy Balance Calculation as per the process requirement to design the adequate relief systems.Work to enhance safety and protection of the environment through overall relief project development.Stay abreast of corporate and industry relief practices and standards such as API 520/521, NFPA 30, API 2000 etcRequirements:3 to 8 years of direct Relief Systems experience in process design, commissioning, start-up, or operations.Demonstrated project management skills. Proficiency with Microsoft Office programsPrefer knowledge in application and compliance requirements of regulatory codes: US Occupational Health and Safety Administration, Internal Process Safety StandardsExperience in a petrochemical plant or refinery Experience with the following software would be an advantage: SuperChems, ASPEN, HTRI, AFT ARROW, AFT Fathom.Addition Required Qualifications/Job Requirements:Master’s or bachelor’s degree in chemical engineering from accredited university or college.Understand process flow diagrams, piping and instrumentation diagram and equipment layouts, conceptual equipment layouts, process layout, utility layout and other block layouts.Understand Plant process design with equipment sizing & utility load design calculation. Must have strong interpersonal, communication, collaboration, and consultation skills. This position will interact with personnel in all organizations.Ability to organize, prioritize, and execute a heavy workload simultaneously within budget and schedule.Must have the ability to communicate effectively through verbal and written means, and able to adapt communication to best reach the intended audience within or outside the organization.Strong customer focus, with demonstrated ability to solve complex issues and work in partnership with peers, Manufacturing, and other stakeholders.Ability to compile and analyze complex data.Knowledge in application of industry standards, recommended practices, and codes (API, NFPA, ASME, etc.)Ensure regulatory compliance of process changes- Provide and communicate clear, concise, and timely reporting of project progress and accomplishments verbally and in writing. 

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16 medical device Jobs found

AVP Delivery Infrastructure

Regulatory Affairs Professional (Product Regulatory Expert)

Product Specialist - Ultrasound Devices ( Sales)

Ecom Manager

Business Development Lead (Global Role)

Regulatory Affairs Manager

OT Project Manager_NOF

ASC Civil Structural Design Engineer

National Sales Manager - Devices

Chemical Engineer – Relief Systems Process Safety

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16 medical device Jobs found

AVP Delivery Infrastructure

Regulatory Affairs Professional (Product Regulatory Expert)

Product Specialist - Ultrasound Devices ( Sales)

Ecom Manager

Business Development Lead (Global Role)

Regulatory Affairs Manager

OT Project Manager_NOF

ASC Civil Structural Design Engineer

National Sales Manager - Devices

Chemical Engineer – Relief Systems Process Safety

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

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