- Abbott (Pleasanton, CA)
- …and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart Failure Division on-site in… more
- BeiGene (San Mateo, CA)
- …+ Accountable for output/summary report for inclusion into clinical, filing, and post - market reports + Accountable for daily, weekly, and monthly review ... executes Crisis Management response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature of response, best course of… more
- GRAIL (Menlo Park, CA)
- …and safety risk management for all GRAIL products during the product development and post - market surveillance phases. This leadership role will be within the ... Quality, Regulatory and Clinical Compliance organization, and will collaborate with...Affairs, and Quality for the implementation and compliance of post -marketing risk management commitments. + In collaboration with Clinical… more
- Abbott (Santa Clara, CA)
- …Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post - market Surveillance Group, Clinical Affairs, Risk ... device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of… more
- Robert Half Technology (Sunnyvale, CA)
- …related to QMS functionalities, including Post Market Surveillance , Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. + Develop ... teams to gather requirements, develop custom solutions, and ensure compliance with regulatory standards. Our client is a leading provider of innovative solutions in… more
- J&J Family of Companies (Santa Clara, CA)
- …is preferred. * Understanding of Statistical Analysis used to identify issues in post - market surveillance , complaints, and servicing is preferred. * ... company engineering teams, including teams representing R&D, Product Quality, Regulatory , and Supplier Quality. Provides engineering, risk assessment, and statistics… more
- Teleflex (Pleasanton, CA)
- …management reports to assess the risks associated with a product. 3. Analyze post - market surveillance data periodically throughout a product's lifecycle to ... throughout the organization. **Principal Responsibilities** Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and… more
- Actalent (Santa Clara, CA)
- …service order requests etc. * Support Quality Compliance activities by extracting and analyzing post market surveillance (PMS) data to support the PMS ... plans/reports, Periodic Safety Update Reports for submission to regulatory bodies * Support comprehensive literature searches, review of complaints, CAPAs and… more