- Integra LifeSciences (Princeton, NJ)
- …or external audits as the Subject Matter Expert for Post Market Surveillance + Participate in site or global projects and improvement efforts, as needed ... set new standards of care. The Quality Engineer II, Post Market Surveillance is directly...Responsible for any changes or updates to the applicable Global Operating Procedures and/or Templates + Participate in internal… more
- Actalent (Minneapolis, MN)
- Job Title: Post Market Surveillance Specialist Job Description We are seeking a diligent Post Market Surveillance Specialist to maintain complete ... of FDA/ISO certified environment + Knowledge of medical device terminology + Surveillance + Documentation review + FDA compliance + Biotechnology + Complaint… more
- Actalent (Minneapolis, MN)
- Now Hiring an Post Market Surveillance Specialist Must be located in the MN Job Description We are seeking a diligent Post Market Surveillance ... and Hospital* 401(k) Retirement Plan - Pre-tax and Roth post -tax contributions available* Life Insurance (Voluntary Life & AD&D...until Dec 9, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** The Post Market Surveillance Manager - Medical Events Team ... Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of… more
- Taiho Oncology (Princeton, NJ)
- …rapidly evolving organization. Position Summary: The incumbent will be responsible for global medical surveillance for the Taiho, marketed and/or investigational ... medical surveillance and risk management, signal detection, on a global basis within the pharmaceutical industry. + Demonstrated leadership in medical … more
- US Tech Solutions (North Chicago, IL)
- **JOB SUMMARY:** + Under general direction, the ** Post Market ** Quality Assurance (PMQA) Analyst I will investigate and maintain **complaint files,** in ... multiple tasks and expectations. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total… more
- Edwards Lifesciences (Irvine, CA)
- …This role will partner closely with other downstream functions in THV including post - market surveillance , global complaint handling and engineering, ... with sustaining activities for commercialized products + Experience in post market investigations, complaint investigations, CAPA investigation, development… more
- Teleflex (Morrisville, NC)
- …Post Market Clinical Follow Up, Summaries of Safety and Clinical Performance, Post Market Surveillance , Risk Management Reports as part of the ongoing ... Associate Global Medical Safety Director (Part Time/Remote US) **Date:**.../ Other Requirements** * Strong understanding of medical device market needs and current offerings * Ability to critically… more
- Danaher Corporation (Brea, CA)
- …handling, adverse event reporting and vigilance reporting. This position is part of the Post Market Surveillance (PMS) team and is an onsite position ... that address the world's biggest health challenges. The Manager Post Market Vigilance ( Post ...maintaining timely Adverse Event reporting as required per appropriate global regulatory agencies. Liaise and collaborate with key stakeholders… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US - Remote Opportunity Requisition ID: 5424 Location: Deerfield, IL, US Do you want to join a team where the mission is ... you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of… more
- System One (Lakewood, CO)
- …of investigational products that are in the early, clinical development, and post - market stages. Functions as medical reviewer for clinical trials and ... Title : Global Medical Safety Clinician - RN, BSN, NP...and other safety-relevant data for the purpose of signal surveillance , detection, and processing + Authors risk and/or benefit-risk… more
- Stryker (Fremont, CA)
- …processes. Assess and trend in-trial metrics including: patient risk and report to post - market surveillance as appropriate. Underlying goal is to obtain ... learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The **Director, Global Clinical Evidence and Medical Affairs** provides direction… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …support both local and global targets and objectives. + Work with the Post - Market Surveillance department to establish tools and methods needed to ... is likely not legitimate._ **Job Description** The Manager, Senior Global MDR Submission is responsible for managing Market... Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment… more
- Kelly Services (Sunnyvale, CA)
- …changes. + Act as the lead for QMS/Compliance activities, such as audits, Post Market Surveillance , Nonconformances (NC), Corrective and Preventative Actions ... in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** Remote **Shift** : M-F, standard… more
- AbbVie (Mettawa, IL)
- …data, guidelines and value proposition). Responsibilities: 1. In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR ... value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with marketing and commercial teams to… more
- Kelly Services (Bridgewater, NJ)
- …documents as part of the Technical File (eg PMS Report, PSUR, PMS Plan + Prepare Post Market Surveillance (PMS) documents as part of the Technical File (eg ... to the implementation of EU-Medical Device Regulation (MDR) and global regulation activities as assigned in the Global...Audits (Internal and Notified Body) and Inspections related to Post - Market Surveillance + Generate periodic… more
- LSI Solutions (Victor, NY)
- …the following areas: Domestic, European, Rest of World, Labeling, and/or Clinical & Post Market Surveillance . Regulatory Associates assigned to Clinical ... with over a dozen product families in US and global markets and others in late-stage development, with products...brochures, post - market clinical follow-up, and post market surveillance . All Regulatory… more
- Terumo Medical Corporation (Somerset, NJ)
- …3940 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Post Market Surveillance Terumo Medical Corporation (TMC) develops, ... such as Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and execution. **Job… more
- Cardinal Health (Columbus, OH)
- …the production of clinical documents; with a focus on Clinical Evaluation Reports and Post Market Surveillance Plans and reports required for CE marked ... Medical Segment devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Surveillance Plans and Reports as… more
- Stryker (Flower Mound, TX)
- …event reporting. + Train Technical Service and Support teams on compliance with post - market surveillance requirements. + Collaborate with key partners to ... business processes related to product returns, failure analysis and support post - market product surveillance activities. Candidate must reside within… more