- BD (Becton, Dickinson and Company) (San Diego, CA)
- …preferred + RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs /Compliance experience in medical devices + Experience with ... **Job Description Summary** As Staff Regulatory Affairs Specialist, you will be...to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Problem solve… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This **Principal Regulatory Affairs Specialist** position is an onsite opportunity working ... Vascular Division. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory ...or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory… 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… 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
- United Therapeutics (Sacramento, CA)
- …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 biologic ... ( **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 of… 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
- 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 ... **Kelly(R) Science & Clinical** is seeking a Sr. Regulatory Affairs Manager for a contract-to-hire position at a cutting-edge client in Seattle, WA . If you're… more
- Stryker (San Jose, CA)
- …live out Stryker's mission to make healthcare better. **Opportunities Available** As a Regulatory Affairs (RA) intern at Stryker, you will gain exposure to ... insight into the collaborative design and development process + Support post-market regulatory reporting projects that help monitor device performance and… 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 Manager, ... International Regulatory Affairs , to expand global access to...+ 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). +… more