- J&J Family of Companies (Irvine, CA)
- …A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is required. Medical ... & Johnson is currently seeking a Senior Manager, Source Regulatory Compliance to join our Regulatory Compliance...is preferred. + Strong knowledge of FDA & Global Medical device regulations & Medical … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class ... Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical Affairs,... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Abbott (Alameda, CA)
- …5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment ... are in place to meet global regulatory requirements. Provide metrics on medical events to support management of product quality issues. **What You'll Work… more
- Meta (Burlingame, CA)
- …**Minimum Qualifications:** Minimum Qualifications: 8. 7+ years of industry experience in medical device regulatory affairs or related industry 9. ... commercialized in the smart wearables and software as a medical device direct to consumer space. You... landscapes and driving successful product registrations. **Required Skills:** Medical Devices , Regulatory Affairs Lead… more
- Meta (Burlingame, CA)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ...and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high- quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
- Abbott (Pleasanton, CA)
- …in a Quality , Regulatory , or product development role in the medical device industry. + 5+ years' experience managing a team of technical/ quality ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... recommend, and implement basic process improvement solutions to trial workflow timelines (eg, device accountability data) + Partner with Quality to resolve … more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Influence and collaborate effectively across the organization,** including with clinical, regulatory , quality , commercial, and manufacturing teams, to align on ... robust design control and risk management practices** are followed across all device programs, in alignment with global regulatory requirements (eg, FDA,… more
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