- 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
- 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
- Tools for Humanity (San Francisco, CA)
- …supporting the Worldcoin open-source protocol by managing Tools for Humanity's legal affairs globally. We collaborate across the company to advance the blockchain ... and enhance our products, including the Orb (our hardware device ), World ID, World App, and World Chain. We...with the Worldcoin Foundation and other partners to ensure regulatory compliance in areas such as securities, AML/CFT, consumer… more
- Teleflex (San Francisco, CA)
- …an optimal customer experience. Collaborating with Marketing, Sales, Engineering and Clinical & Medical Affairs on key projects and initiatives, the CSS utilizes ... innovation, our Arrow brand of technically advanced vascular access devices are renowned throughout the world. Many of our...**Specialized Skills / Other Requirements** + 2+ years of Medical Device Industry experience. + 3+ years… 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
- 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… more
- GRAIL (Menlo Park, CA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… 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. ... medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including… 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
- 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 (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 (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritional's and branded generic medicines....scientists. + The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our… more
- Stryker (Fremont, 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
- Veterans Affairs, Veterans Health Administration (San Francisco, CA)
- …services to disabled patients. This work requires a specialized knowledge of the medical and psychological problems directly related to the use of prosthetic and ... orthotic devices ; and specialized knowledge and understanding of the fabrication...determine expectations, lifestyle, home/work environment, ability to use the device . 5. Takes necessary measurements, casts or scans to… more
- Edwards Lifesciences (San Francisco, CA)
- Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate ... environment with cross-functional collaborators + Substantial knowledge and understanding of medical affairs policies, procedures, and guidelines, including … more
- Abbott (Alameda, CA)
- …monitor the performance of marketing programs, and adjust tactics as needed + Partner with Regulatory Affairs , Medical Affairs , Legal, and OEC colleagues ... years of experience in product marketing in healthcare, pharmaceutical, medical device , or a regulated industry. **Preferred...of applicable regulatory standards and requirements for medical devices or Rx products preferred. The… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... Affairs Manager will manage teams within the Medical Affairs Sub-Function. Focus is on policy...and provides reporting information for reports submitted to the regulatory agencies. + Monitors adherence to protocols and determines… more
- Abbott (Alameda, CA)
- …value. + Collaborate with cross-functional teams including Insights, Design, Data Science, Regulatory , Medical Affairs , and Technology. + Provide strategic ... 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)
- …and manage the digital health analytics + Work cross functionally with market access, regulatory affairs , medical and clinical resources to deliver on ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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
