- Philips (Gainesville, FL)
- The Director-Global Data Analytics- Post Market Surveillance will oversee the strategic use of data to include operational activities used to effectively ... support post market surveillance activities, per...data collection and reporting activities + Reporting to the Sr Director-Global Data Analytics & Risk Management, you will… more
- West Pharmaceutical Services (Exton, PA)
- …global regulatory filings, information request responses, change notifications, and post - market surveillance reports/compliance reports. + Independently ... Sr . Specialist, Regulatory Project Mgmt Requisition ID: 66496...Management, including change controls, device complaint investigations, CAPAs, and post - market surveillance . + Regulatory Affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …work on IP specific activities the IPL will participate in standing committees, review post market surveillance trends, perform due diligence reviews, and ... new product development processes, R&D engineering, risk management, clinical trials, post - market safety surveillance , health hazard assessments and… more
- West Pharmaceutical Services (Exton, PA)
- …Analytical Labs, Supply Chain, and Operations in support of product development, launch, and post market surveillance activities. The incumbent will be a ... Sr Quality Engineer, Integrated Systems Requisition ID: 66823...(eg, Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities +… more
- LSI Solutions (Victor, NY)
- …awareness of device trends and identify opportunities of improvement. + Communication of post - market surveillance and trend analysis pertinent to the ... the patient. POSITION TITLE: Surgical Device Engineer I, II, Sr SHIFT HOURS: 8:00am to 5:00pm LOCATION: Onsite at...testing, and Summative Usability testing. + Level II & Senior : Direct Usability Engineering process of new product within… more
- Danaher Corporation (Boulder, CO)
- …PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post - market surveillance activities, etc. + Author and/or ... review regulatory documents for submission and global market entry providing regulatory expertise to team and effective communication to Sr . Leadership to ensure… more
- AbbVie (Branchburg, NJ)
- …including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review. + Provide in-depth insights ... represent Branchburg in above-site reviews when required. Own and maintain procedures for Post Market Surveillance , Quality Management System Review, and… more
- ThermoFisher Scientific (Waltham, MA)
- …from different countries and regions. Work closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is completed. Supports ... will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a member of the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of issues prior to release and any issues that may present from the post - market surveillance teams. + Quality representative in risk management activities ... a highly motivated, results-focused professional to join our team as a ** Senior ** **Quality Engineering Manager - Software** . The Quality Engineering Manager's… more
- Fresenius Medical Center (Lawrence, MA)
- …for the implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope of complaints/incidents and ... vulnerability management coordination of product related cybersecurity activities . Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy **Experience** . 2+ years of relevant experience in medical device… more
- Danaher Corporation (Westborough, MA)
- …device, pharmaceutical) required + At least 3 years relevant experience dealing with post market surveillance and QA activities (complaint triage, ... to develop the next generation of life-changing therapeutics. The Senior Quality Assurance Engineer for Cytiva is responsible for...with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance + Excellent… more
- J&J Family of Companies (Raynham, MA)
- … registration and throughout life cycle. + Work with Medical Safety and Post - Market Surveillance to assess, analysis and interpret events, complaints, ... Senior Director, Medical Affairs Orthopedics - 2406206569W **Description**...product development, including evidence generation and dissemination that drive market registration, access, and adoption. This role supports medical… more
- Taiho Oncology (Princeton, NJ)
- Sr . Director, PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July 15, 2024 Looking for a chance to make a meaningful difference in the oncology ... on a transformative journey with Taiho Oncology as a Sr . Director, PV Medical Surveillance . At...analysis of safety data from clinical trials and from post -marketing sources, providing medical expertise to assigned project teams,… more
- Medtronic (Minneapolis, MN)
- …Safety Specialist, Literature, MDR/Vigilance provides a review of medical literature for Post - Market Product Surveillance . This position will continually ... with multiple functions including Research and Development, Risk Management, Quality/ Post - Market Vigilance (PMV), Regulatory, and Clinical Affairs. This… more
- ManpowerGroup (South San Francisco, CA)
- …and trending activities, such as data analysis, internal/external audits, CAPA related activities, post market surveillance + Work with software partners to ... ** Senior Manager, Medical Device Technology, Complaint Handling** Our...803. + Demonstrated experience with leading teams responsible for post market complaint investigations for medical devices… 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 ... pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** Remote **Shift** :… more
- Medtronic (Minneapolis, MN)
- …experience + Experience with patient data and clinical reporting + Knowledge of pre/ post market surveillance and real-world evidence + Strong knowledge ... or onsite at a US-based Medtronic facility. As a Senior Principal IT Business Analyst on the Product DNA...in medical technology and healthcare solutions - we're a market leader and growing every day. You can be… more
- Abbott (Santa Clara, CA)
- …regulatory strategies, and medical writing expertise to support marketing applications and post - market surveillance filed with China National Medical ... fingersticks. **The Opportunity** We currently have an exciting opportunity for a ** Senior Project Manager, Clinical Evaluation - China** available on-site in Santa… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Evaluation Report for products under their respective platforms and ensures MA aspects of Post Market Surveillance + Drives innovation under their respective ... toxicology to clinical, and human factors, as well as post marketing follow up. The Platform Lead develops a...ensures these plans are aligned with the business and market access needs + Engages with Subject Matter Experts,… more
- Danaher Corporation (New Brighton, MN)
- …The RA Associate will also assist with post - market activities including post - market surveillance , adverse event reporting, and field actions. The RA ... of the Quality Assurances and Regulatory Affaris Team and report to the Senior Manager, QARA responsible for regulatory Compliance. If you thrive in a… more