- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... on developing novel nanomedicines, HD therapeutics (HDTs), to treat unmet medical needs in ophthalmology, neurology, inflammatory diseases, and neuro-oncology. Our… more
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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
- Stryker (Fremont, CA)
- …with a solid understanding of regulatory standards and practices. + Exposure to Medical Device Regulatory Affairs or Engineering through coursework, ... Fremont, CA or Salt Lake City, Utah as a Regulatory Affairs Specialist.** At Stryker, we're driven...experience working with US Class II and Class III medical devices. + Demonstrates strong analytical and writing skills,… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… 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...fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...in a timely manner. + Experience working in the Medical Device industry. + Certification is 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
- Gilead Sciences, Inc. (Foster City, CA)
- …goals, and results to team members across functions and departments, including device development, packaging, quality, regulatory affairs and manufacturing. ... + Experience in the pharmaceutical or biotechnology industry is preferred + Medical device or combination product experience is preferred + PMP certification is… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... projects and issues affecting development of new products or medical devices or new indications for existing products +...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- J&J Family of Companies (Santa Clara, CA)
- …reports, and regulatory submissions. + As needed, assist in the Medical Affairs review of advertising/promotional/education material. + Support the Clinical ... and scientific information while adhering to legal, compliance and regulatory requirements. The Principal Medical Sciences Specialist...minimum of 8 years of relevant Medical Affairs experience in the Medical Device… more
- Abbott (Pleasanton, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Roche (Santa Clara, CA)
- …with expertise in Companion Diagnostics. + Knowledge in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP's and ... ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to...you will be a member of the companion diagnostics Regulatory Affairs Leadership team. In this position,… more
- Abbott (Pleasanton, CA)
- …budget and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs , ... a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure...data science teams and operating in a highly cross-functional medical device environment desirable. Global experience preferred.… more
- J&J Family of Companies (Santa Clara, CA)
- …to interface cross-functionally across Commercial, Market Access, Sales, Clinical, Legal, and Medical Affairs teams. The Director will play a pivotal role ... process, and a legacy of strategy development within the medical device market. The role will also...strong partnerships with internal cross-functional leaders (eg, Sales, Marketing, Medical Affairs , Legal, Compliance). + Serve as… more
- Abbott (Santa Clara, CA)
- …stake holders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs , medical affairs as well ... **Preferred Qualifications** + MS Office Suite, highly preferred + Experience in the medical device industry, highly preferred + Experience with clinical trials,… more
- Abbott (Pleasanton, CA)
- …+ Two (2) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or other similarly ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… 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
- J&J Family of Companies (Santa Clara, CA)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Professional Medical ... Management); or other applicable experience is required + Previous experience in Medical Device Education (external or internal stakeholder training) is required… more
