- 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 ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… 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
- 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
- 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
- Stryker (San Jose, CA)
- …live out Stryker's mission to make healthcare better. **Opportunities Available** As a Regulatory Affairs (RA) intern at Stryker, you will gain exposure to ... insight into the collaborative design and development process + Support post-market regulatory reporting projects that help monitor device performance and… more
- Abbott (Santa Clara, CA)
- …stake holders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs , medical affairs as well ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....MS Office Suite, highly preferred + Experience in the medical device industry, highly preferred + Experience… more
- Actalent (Santa Clara, CA)
- …+ 2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry. + Strong ... such as R&D, Manufacturing, and Regulatory . + Determine regulatory reportability and submit Medical Device Reports (MDRs) to the appropriate agencies. +… more
- J&J Family of Companies (Santa Clara, CA)
- …the requirements for sponsors involved in clinical investigations of medical devices . + Collaborate with quality and regulatory teams to maintain compliance ... and leadership of cross-functional teams to reach risk-based decisions in complex capital medical device product reviews. + Uses analytical skills and innovative… more
- 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 ... can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan...other departments including Global Clinical Operations, Research & Development, Regulatory Affairs , and Biostatistics. + Writes, study… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and...desired):** **Preferred Skills** **/ Tools:** + Deep experience in medical device clinical research + 10+ years… more
- Edwards Lifesciences (San Jose, CA)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- J&J Family of Companies (Santa Clara, CA)
- …**4. Cross-Functional Collaboration** + Collaborate with Market Access, Health Economics, Medical Affairs , and Compliance teams. + Provide field insights ... role in supporting patient access to our therapies and devices by providing expert reimbursement and access support to...field with emphasis on coding, coverage, and payment issues; medical device experience preferred. + 5-7 years… more
- 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 ... + Partner with cross-functional teams such as upstream marketing, regulatory affairs , clinical, R&D, and legal to...to the success in the roles. **Preferred Qualifications** + Medical device experience is preferred. + Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with comprehensive root-cause analysis, risk assessment, and effective CAPAs **Compliance & Regulatory Affairs ** + Ensure QC operations comply with cGMP, FDA, ... determine appropriate strategy and resources for resolution of problems + Knowledge of medical devices and combination products is a plus. **Gilead Core Values**… more
- Imperative Care (Campbell, CA)
- …directly with customer representatives, marketing, physicians, pre-clinical engineering, and regulatory affairs to understand user interactions, identify product ... discipline and a minimum of 8 years of related experience developing flexible medical device instruments; or equivalent combination of education and work… more
- 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 ... cross-functional teams or work groups + Demonstrated understanding of pharmaceutical/ medical technology regulatory requirements and impact on development… more
- FocusKPI Inc. (Mountain View, CA)
- …+ Meeting with key stakeholders (PM, Head of User Experience and Human Factors, Regulatory Affairs , Head of Engineering) to understand key milestones for product ... on consumer health products and developing products in the health, wellness, and/or medical space. + Experience with products that seek to motivate users to make… more
- Gilead Sciences, Inc. (Foster City, CA)
- …digital tools and analytics per our **Quality digital roadmaps** **Compliance & Regulatory Affairs ** + Ensure site-wide compliance with cGMP, FDA, EMA, ... and new applications based on quality principles and theories. + Knowledge of medical devices and combination products is a plus. + Demonstrated an ability to… more
