- Actalent (Miami, FL)
- …Regulatory affairs , Regulatory , document control, bilingual, fda, medical device , RAPS Additional Skills & Qualifications -Bachelors degree in ... Responsible for Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements * Responsible for Device Registration...Engineering / Regulatory Affairs -1-3 years experience -Strong Technical… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …related to licensing activities, Source Plasma collection and medical device regulations. + Maintain up-to-date knowledge of regulatory requirements and ... and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary… more
- Stryker (Portage, MI)
- We are seeking a **Principal Regulatory Affairs Specialist** to join our ** Medical Division** . This **Hybrid** role will be based in **Portage, MI** , ... device regulations** **.** **Preferred** + At **least 5** years in medical industry, Regulatory Affairs or Engineering. + **RAC certification** or… more
- Gilead Sciences, Inc. (Washington, DC)
- …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
- GE HealthCare (Waukesha, WI)
- …discipline or a minimum of 8 years work experience. + A minimum of 4 years Regulatory Affairs / Quality Assurance experience + A minimum of 4 years' experience ... in the medical device or pharmaceutical industry + Strong...management skills. + Advanced degree in scientific, technology or regulatory affairs disciplines + Regulatory … more
- Bristol Myers Squibb (San Diego, CA)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Associate Principal, Regulatory Affairs **Job Description:** Responsible for establishing and preparing strategy for worldwide product ... evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications,...San Francisco Fair Chance Ordinance. **External-Facing Title:** Associate Principal, Regulatory Affairs **Posting Country:** US - United… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for the assigned drug/ device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... Health Authority. **A typical day might include:** + Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications,… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more