- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... / IDE and international submissions + Experience with combination product and/or Class III medical devices + Experience with IDE trial strategy and post market… more
- Edwards Lifesciences (Irvine, CA)
- …and critical thinking skills + Full knowledge and understanding of global regulations relevant to medical devices , Class II and/or Class III devices + Full ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… 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
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in Alameda, CA...submissions (PMA, IDE, 510(k)) for Class II, and III medical devices or EU Technical Files or… more
- Ascendis Pharma (Palo Alto, CA)
- … regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA, ... advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products… more
- Abbott (Santa Clara, CA)
- …meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series. **Principal ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....Biocompatibility support to the research & development of new medical device products as well as the… more
- Ascendis Pharma (Palo Alto, CA)
- …drug- device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing ... mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly… more
- Amazon (Sunnyvale, CA)
- …originally creating the best-selling Kindle family of products. Since then, we have produced devices like Fire tablets, Fire TV, and Echo. What will you help us ... ambitious and complex compliance challenges through research, engagement with regulatory agencies, hands-on testing, debugging, and validation activities. You must… more
- BeOne Medicines (Emeryville, CA)
- …formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual… more
- United Therapeutics (Sacramento, CA)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more