- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support,… more
- Insight Global (San Diego, CA)
- …and international quality regulations. Seeks expert advice and develops device regulatory product strategies and identifies data and information requirements ... also offers the opportunity to work alongside the IVD Quality team in the development and implementation of processes...or related life sciences Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical … more
- Kelly Services (Valencia, CA)
- …Onsite in Valencia & Burbank, CA + **Salary:** $100,000-$140,000/year (DOE) + **Industry:** Medical Device / Life Sciences Kelly(R) Science & Clinical is hiring ... a ** Regulatory Affairs Manager** for a leading client. In this...and CAPAs; train auditors. + Manage document control, sealed source/ device registries, and complaint programs. + Prepare/approve procedures, ECOs,… more
- United Therapeutics (Sacramento, CA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …direct professional experience ( Regulatory ) in increasingly responsible positions in the medical device field and seven (7) years of management experience + ... possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the world...a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Kelly Services (Oakland, CA)
- …related experience, or PhD + 5 years of related experience . 6-8 years of regulatory experience in a medical device and/or diagnostics company involved with ... event of notifiable nonconformances or adverse events . Owns and manages applicable regulatory processes and documents . Works with quality system process owners… more
- Meta (Sunnyvale, CA)
- **Summary:** As a Hardware Regulatory Readiness and Compliance Technical Program Manager at Meta, you will play a critical role in crafting our compliance strategy ... to ensure that our products meet regulatory requirements and industry standards. You will work closely with cross-functional teams to drive compliance across… more
- Stryker (San Jose, CA)
- …a related field + 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). + Experience leading and ... access strategies, leveraging advanced project management practices in areas such as regulatory , quality , risk, procurement, and stakeholder engagement. You will… more
- Terumo Neuro (Aliso Viejo, CA)
- …3. Strong knowledge of medical device development processes, regulatory requirements, and quality management systems. 4. Excellent analytical skills to ... enhancements. + Stay current with industry trends, regulations, and best practices in medical device project management, and apply them to improve project… more