- San Jose State University (San Jose, CA)
- …experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs , clinical and ... discipline, and a minimum of 3-5 years related experience in a medical device , pharmaceutical, In Vitro Diagnostics, and/or Clinical Research Organization… more
- J&J Family of Companies (Santa Clara, CA)
- …**Job Description:** Johnson & Johnson is hiring for a **Principal** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical ** to join our team located ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...for Shockwave Medical Inc. (SWMI). The Principal Regulatory Affairs Specialist combines knowledge of scientific,… more
- Amazon (Sunnyvale, CA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... - . Strong written, verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability to identify risk areas… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director, Regulatory Affairs will be responsible for developing and implementing global ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- J&J Family of Companies (Santa Clara, CA)
- …**You will be responsible for:** + Learn the basics of medical device development, design, clinical use, and regulatory requirements for Shockwave Medical ... https://www.jnj.com/medtech We are searching for the best talent for ** Regulatory Affairs Intern** to be in **Santa...Biocompatibility, or Regulatory Sciences. + Knowledge in medical devices/ medical device regulations. +… more
- J&J Family of Companies (Santa Clara, CA)
- …in medical affairs , clinical development or related roles in research/ medical device industry is _strongly preferred_ . + Experience in Minimally ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical … more
- J&J Family of Companies (Santa Clara, CA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Stryker (San Jose, CA)
- …States. **What you will do** Serve as a technical leader for the Regulatory Affairs organization, with focus on product environmental compliance projects across ... regulatory requirements. + Set direction and strategy for regulatory affairs organization and department projects. +...work experience required . + 2-4 years experience in medical device with Bachelors or 1 year… more
- J&J Family of Companies (Santa Clara, CA)
- …Overview** The Principal Clinical Evaluation Specialist requires experience in the writing of medical device clinical regulatory documents. The position will ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Meta (Sunnyvale, CA)
- …in an organization that is primarily consumer electronics focused but has a growing medical device portfolio to champion the adoption of processes. You will work ... as part of the Regulatory Affairs and Quality Systems team executing...activities for electromechanical devices and/or in software as a medical device (SaMD). **Required Skills:** Medical… more
- Meta (Sunnyvale, CA)
- …appropriate on several projects as a part of our Regulatory Affairs and Quality Systems for Medical Devices squad **Public Compensation:** $139,000/year ... in an organization that is primarily consumer electronics focused but has a growing medical device portfolio of hardware and software products. You will be both… more
- Meta (Sunnyvale, CA)
- …in an organization that is primarily consumer electronics focused but has a growing medical device portfolio to champion the adoption of processes. You will act ... share their domain experience in electromechanical devices and/or in software as a medical device (SaMD) in product core teams. **Required Skills:** Medical… more
- Abbott (Santa Clara, CA)
- …for real-world evidence studies across the business. + Partner with leaders in clinical affairs , regulatory , medical affairs and marketing for project ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...selection and prioritization. + Communicate with regulatory agencies and payer organizations on real-world studies. +… more
- Stryker (Fremont, CA)
- …will work closely with cross-functional teams-including R&D, marketing, sales, and regulatory affairs -to ensure successful launches and maximize market adoption ... a comprehensive pricing strategy to explore innovative pricing models beyond traditional medical device structures. + Build business cases and financial models… more
- J&J Family of Companies (Santa Clara, CA)
- …with a diverse team of Design Engineers, Development Engineers, Quality Engineers, Regulatory Affairs , Marketing, and Clinical. + Meet with Quality management ... quality engineering related experiences. + Knowledge of FDA or regulatory guidance. + Medical related experience (previous...+ Medical related experience (previous co-op at medical device company, working volunteering at a… more
- J&J Family of Companies (Santa Clara, CA)
- …skills and partnership with R&D, Global Strategic Marketing, Product Marketing, Regulatory Affairs , Supply Chain, Quality and Finance. **Major Duties ... Finance. + Collaborates with R&D, GSM, Supply Chain, Quality, Regulatory , Service, and other cross-functional partners to ensure all...is highly desirable. + PMP Certification is desirable. + Medical device experience with Class II, III… more
- Olympus Corporation of the Americas (San Jose, CA)
- …+ Minimum of 5-7 years experience working with quality systems preferably in a medical device company. + Must possess excellent organizational skills with the ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs … more