- Parexel (Sacramento, CA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as...development plans. + Act as the representative of European regulatory team at the global regulatory… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... cross functions on the team to ensure alignment of global regulatory strategy with the team objectives....solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects… more
- Teleflex (San Francisco, CA)
- …: More than 50% **Requisition ID** :12837 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve ... relevant policy and procedures, evidence-based practice guidelines and mandated regulatory requirements. Working closely with healthcare providers and their teams… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate,… more
- Abbott (Alameda, CA)
- …Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative and drive the next ... and mentor a high-performing QARA team with deep expertise in software quality, regulatory affairs , and medical device compliance. + **Post-Market… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …relevant experience. + Master's Degree (10+ years), Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will ... who may require assistance understanding complex rules governing medical device industry. + Ensure compliance with global ... affairs . + 3+ years of related regulatory submission experience from a medical device … more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …relevant experience. + Master's Degree (10+ years), Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will ... and impact of changes and support international counterparts in global regulatory submissions/approval. + Prepare, coordinate, and... affairs . + 3+ years of related regulatory submission experience from a medical device … more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible ... for assigned products. Product portfolio will include pharma, OTC, and/or device or combination products. + Lead cross-functional labeling teams to develop… more
- Medtronic (Irvine, CA)
- …an accredited college or university required. + Minimum of 4 years of experience in medical device regulatory affairs + Or advanced degree with a minimum of ... 2 years of experience in medical device regulatory affairs **Nice To...Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards +… more
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