- AbbVie (Irvine, CA)
- …works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and ... influence, and provide strategic advice. Additional Responsibilities Include: + Prepares device regulatory product strategies. Prepares and manages regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …or other technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with ... technical product expertise (Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated medical … more
- Abbott (Pleasanton, CA)
- …cross-functional project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA, ISO 13485). ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- CTG (Woodland, CA)
- …Biology preferred) **Qualifications** * Minimum 3 years' experience in Quality or Regulatory , preferably in medical device , pharmaceutical, or biotechnology ... Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment with site quality goals and metrics.… 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 ... medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific… more
- Actalent (Santa Clara, CA)
- …oversight on proper documentation for regulatory submissions. Essential Skills + Medical device experience and understanding of an ISO13485 environment. + ... it into clear documentation for internal and external use in a medical device environment. Responsibilities + Distill technical information into accessible… more
- Danaher Corporation (Sunnyvale, CA)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... plus if you also possess previous experience in: + ISO 9001:2015 + Regulatory Intelligence Cepheid, a Danaher operating company, offers a broad array of… more
- Danaher Corporation (Sunnyvale, CA)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... Certification + ISO 9001:2015 process and assessment certification activities + Regulatory Intelligence program + Technical Writing Cepheid, a Danaher operating… more
- Aerotek (Irvine, CA)
- ** Medical Device Assembler I - 1st Shift** **Job Description** We are seeking a dedicated Assembler I who will be responsible for assembling and testing ... microscope 90% of the shift. **Additional Skills & Qualifications** + Experience in medical device assembly. + Cleanroom experience is preferred. + Proficiency… more
- Aerotek (Irvine, CA)
- **HIRING 1st Shift Medical Device Assembler** Job Description We are seeking a dedicated Assembler I to join our team on a 12-18 month contract. This role ... High School Diploma or equivalent. Additional Skills & Qualifications + Experience in medical device assembly. + Cleanroom experience. + Proficiency with hand… more