- Oracle (Sacramento, CA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Actalent (Lake Forest, CA)
- … Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , FDA CFR, CMC, ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global ...development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU… more
- Abbott (Alameda, CA)
- …high-performing QARA team with deep expertise in software quality, regulatory affairs , and medical device compliance. + **Post-Market Surveillance:** ... is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables...Quality Assurance and Compliance system optimized for Software as Medical Device . In addition, this individual will… 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 ... partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for … more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... abilities and a deep understanding of regulations pertaining to medical devices. The Senior Regulatory Affairs...of related regulatory submission experience from a medical device and/or IVD industry. + Ability… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... focus on regulatory affairs . + 3+ years of related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices. + Class III PMA experience is _preferred_ . ... containing software _preferred_ . + Proven expertise in all aspects of Regulatory Affairs , Submission Preparation, FDA Device Law/Regulations, Worldwide… more