- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- United Therapeutics (Sacramento, CA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product ... + Prepare/approve procedures, ECOs, and testing documentation. + Support quality training and system improvements. + Supervise and develop...+ Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +… more
- Merck (San Diego, CA)
- …+ Oversee and independently lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all ... documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written communications. +… more
- Kelly Services (Sunnyvale, CA)
- …scope for the initial product launch (US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US- FDA , IVDR, WHO/PQ) as required by project plan. + ... goals and meeting timelines + Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions… more
- Terumo Neuro (Aliso Viejo, CA)
- …approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy...+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as… more
- Meta (Burlingame, CA)
- …wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or ... vigilance reporting, product recalls, etc., as needed 3. Prepare FDA , European and Canada submissions for product changes as...Directive/EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards 10. Advanced… more
- Abbott (San Diego, CA)
- …years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, ... female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, CA** location… more
- Robert Half Finance & Accounting (Oakland, CA)
- …costs, identifying optimization opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance. This is ... + Monitor the cost impact of design or process changes associated with FDA approval cycles or regulatory requirements. Continuous Improvement: + Evaluate the… more
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... regulated industry (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and… more