- Abbott (Santa Clara, CA)
- … device business units that Leveraged Services team supports. **The Opportunity** The ** Senior Manager Regulatory Affairs ** will work for our Global ... (FDA) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may...is helpful. + At least 5 years' experience in regulatory affairs ; highly preferred with medical… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... location in the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the … more
- AbbVie (Irvine, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research &… more
- Oura (San Francisco, CA)
- … affairs , or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices, digital health, or wearable ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. + Experience with… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the ... business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in...+ Minimum ten (10) years of direct professional experience ( Regulatory ) in increasingly responsible positions in the medical… more
- Stryker (San Jose, CA)
- ** Senior Project Manager, International Regulatory Affairs ** _San Jose, CA / Flower Mound, TX / Kalamazoo, MI_ Stryker is hiring a Senior Project ... leveraging advanced project management practices in areas such as regulatory , quality, risk, procurement, and stakeholder engagement. You will collaborate… more
- Stryker (San Jose, CA)
- The ** Senior Director, Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more
- BeOne Medicines (San Mateo, CA)
- …for BeOne's marketed products in North America. This role supports our commercial, medical affairs , legal, healthcare compliance and other business functions in ... regulatory requirements and company policies/standards. + May also perform regulatory review for non-promotional medical , HEOR, and corporate/investor… more