- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... US Drug regulations or with EU and other international medical device regulations and submissions. + Familiar...device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices, drugs and/or… more
- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar...device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… more
- Grifols Shared Services North America, Inc (Emeryville, CA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... projects and issues affecting development of new products or medical devices or new indications for existing products +...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Abbott (Alameda, CA)
- …design and on-market development / change teams. The Section Manager will have expertise in medical device Design Controls as well as work with RA on emerging ... internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs . Provide support, as needed, to...The Section Manager will work on new product introduction medical device programs as well as guide… more
- Abbott (Alameda, CA)
- …monitor the performance of marketing programs, and adjust tactics as needed + Partner with Regulatory Affairs , Medical Affairs , Legal, and OEC colleagues ... of 4-6 years of experience in product marketing in healthcare, pharmaceutical, medical device , or a regulated industry. **Preferred Qualifications** + MBA… more
- Abbott (Alameda, CA)
- …and manage the digital health analytics + Work cross functionally with market access, regulatory affairs , medical and clinical resources to deliver on ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Alameda, CA)
- …relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs . Provide support, as needed, to Clinical Material ... in Quality Assurance, Technical Quality. + Minimum 3 years experience in the medical device industry. + Some knowledge in the areas of design controls, V&V… more