- Abbott (Pleasanton, CA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist I** will work on-site out of our Pleasanton,… more
- 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
- Abbott (Pleasanton, CA)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart Failure Division… 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
- 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
- AbbVie (Pleasanton, CA)
- …regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. 2. Advisory Responsibilities * ... biology or other health sciences; plus five-year experience in regulatory affairs . + At least three-year experience.... + At least three-year experience working in a medical device manufacturing company, preferably with capital… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs , Precision Medicine, you will help develop and execute ... Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx ...compliance with IVDR, adherence to GCP, and alignment with Medical Device QMS operations. + In-depth knowledge… 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
- Abbott (Pleasanton, CA)
- …Eight (8) 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
- 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