- Philips (Bothell, WA)
- …10+ years' experience in FDA regulated quality/regulatory environments, with a focus on Post Market Surveillance / Complaint Handling / Regulatory Reporting ... etc.) is required + You have extensive experience/knowledge of most regulations relative to Post Market Surveillance activities and reporting, such as: ISO… more
- Hologic (Marlborough, MA)
- …manage NCEs, CAPAs, SSEs, QPLs, and other quality metrics, and assist in post - market surveillance complaint investigations. + **Risk Management:** Implement ... Senior Design Assurance Engineer Newark, DE, United States...medical devices throughout their lifecycle, from product development to post - market follow-up. Significantly contribute to assessing product… more
- Philips (Cambridge, MA)
- …post -release activities. Conductmarket analysis to understand customer needs, market trends, prices, and competitive landscape, utilizing insights todevelop ... Manager, you will lead the efforts for the Virtual Care and Clinical Surveillance Solutions, where you will focus on driving product commercialization and post… more
- Pfizer (Kalamazoo, MI)
- …and the development of other regulatory submission packages. + Performs data analysis for post market surveillance activities and for internal reports used ... + Ensures device risk management files are updated regularly incorporating post -production information. + Develops and monitors key metrics and provides input… more
- Danaher Corporation (Austin, TX)
- …while working collaboratively with a wide range of new product development and post - market surveillance stakeholder groups. The essential requirements of the ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager, Clinical Quality and Compliance reporting to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …across the development lifecycle - from protocol design through regulatory submissions to post - market safety surveillance . You will lead a global team ... product-driven culture grounded in Takeda's values: Patient-Trust-Reputation-Business. + Collaborate with senior leaders across GDO, GRA, PSPV, and IT delivery to… more
- Bausch Health (Bothell, WA)
- …the assessment of product changes. + Prepare and submit regulatory documents for post - market surveillance , including annual reports, and other required ... the role: Product Lifecycle Management + Oversee the regulatory aspects of post - market activities such as changes, modifications, enhancements, renewals, and… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …+ Non-conformance and deviation handling + Test Method Validation + Supplier Qualification + Post - Market Surveillance + CAPA and Root Cause Analysis + ... service and optimizes resource utilization. + Provide technical support for Post - Market Quality, including complaint investigations and situation analyses. +… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …+ Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance . + Strong working knowledge of statistics, ... sampling strategies, and design of experiments, including statisticalsoftware tools such as Minitab. + Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, andregulatory requirements such as FDA QSR's, ISO13485, ISO… more
- Bio-Techne (Austin, TX)
- …filings, licenses, and registrations while maintaining compliance with QMS and post - market surveillance requirements. + Facilitate regulatory meetings, ... Summary:** The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings and support regulatory… more
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