- 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. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- Medtronic (Santa Rosa, CA)
- …profile._ + Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree ... approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device...heart valve products + Experience with Software as a Medical Device + RAC Medical … more
- J&J Family of Companies (Irvine, CA)
- …Devices sector within **Johnson & Johnson** , is recruiting for an intern for its ** Medical Devices Regulatory Affairs organization** . At **Johnson & ... develop the skills needed to succeed in a global organization. The Intern - ** Medical Devices Regulatory Affairs (MD RA)** opportunity will help you grow… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …communication abilities and a deep understanding of regulations pertaining to medical devices . The Senior Regulatory Affairs Specialist will work closely ... regular audits to ensure compliance with relevant regulations governing medical devices ; identify gaps if any exist...Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider… 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
- 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
- J&J Family of Companies (Irvine, CA)
- … medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices . + Class III PMA experience is _preferred_ . + ... 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA...._preferred_ . + Proven expertise in all aspects of Regulatory Affairs , Submission Preparation, FDA Device… more
- Abbott (Alameda, CA)
- …+ 5+ years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … 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 ... factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. This role is… more
- AbbVie (Irvine, CA)
- …to be a team leader and engage key stakeholders, including global strategic marketing, medical affairs , regulatory affairs , clinical development, and ... be to evaluate the interaction of current and future medical devices with cells and tissues for...methods to support development of novel medical device /tissue products. + Critically evaluate scientific or regulatory… more
- BeOne Medicines (Emeryville, 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 ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Abbott (Santa Clara, CA)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for ... in clinical research, clinical affairs , regulatory affairs , or quality systems, in the medical device or pharmaceuticals industry. + 3-5+ years of… 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
- Abbott (Alameda, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . + Experience of working within ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Sylmar, CA)
- …in Mandarin + Previous regulatory compliance, R&D, and/or quality experience in medical device industry + Good working knowledge of the product development ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist-China. As a Senior … more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...regulatory requirements for medical devices … more