- Regeneron Pharmaceuticals (East Greenbush, NY)
- …+ Senior Director : 15+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience. Advanced ... We are currently looking to fill an Sr Director of Combination Product Development to establish and...regulatory compliance strategies, ensuring robust documentation, design control, and quality risk management for device and packaging… more
- Oura (San Francisco, CA)
- … system, including external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. + Experience with privacy and ... tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a...out of the office. We are looking for a Director , Regulatory Affairs and Quality Assurance to… more
- Terumo Aortic (Sunrise, FL)
- Director Quality Operation Date: Aug 29, 2025...Canadian Quality System Regulation, MDSAP and the Medical Device Regulation (MDR). Job Details: + In ... lives of patients in over 100 countries worldwide. www.terumoaortic.com Director Quality Operation Job Summary: This position...with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements for medical devices. +… more
- Abbott (Santa Clara, CA)
- …by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... Opportunity** The **Associate Director Regulatory Affairs** will work for our Global Regulatory...and leadership on regulatory activities and works with the medical device business units that Leverage Services… more
- GE HealthCare (Bellevue, WA)
- …management experience is preferred. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including ... manufacturing / production process control methodologies, and servicing in a medical device environment. Experience in a global working environment.… more
- BeOne Medicines (Emeryville, CA)
- …+ Minimum of 8+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment + In-depth operational experience in at ... **General Description:** The Associate Director , Digital Quality Management Systems (QMS) Operations and User Experience, is responsible for ensuring the… more
- ThermoFisher Scientific (Bedford, MA)
- …or experience. + 10+ years of experience in the Pharmaceutical, Biotech, or Medical Device industries with regulated products. + 5+ years leading multi-site ... Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Description: Director , Quality - Purification & Pharma Analytics (PPA)**… more
- Teleflex (Wayne, PA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with ... Medical Director , Interventional Urology and Urology...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
- GE HealthCare (Chicago, IL)
- …Qualifications** + Master's Degree and a minimum of 7 years' experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of ... **Job Description** **Roles and Responsibilities** + Executes against the Quality & Regulatory Business Development Process. This includes scheduling,...9 years' experience in the medical device or pharmaceutical industry; or will… more
- AbbVie (North Chicago, IL)
- … Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required. Experience working in a regulatory agency ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Associate Director , Global Quality and Compliance Excellence uses advanced subject… more