- 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
- Jazz Pharmaceuticals (Palo Alto, CA)
- …and commercial manufacturing vendors. Prepares and/or reviews, in conjunction with Regulatory Affairs , the Chemistry and Manufacturing Controls sections of ... or controlled-release dosage forms, and potential novel combination products (ie, drug- device ). The Senior Director, Drug Product Development is responsible for… 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
- 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
- J&J Family of Companies (Santa Clara, CA)
- …to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge ... 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
- 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 (Alameda, CA)
- …high-performing QARA team with deep expertise in software quality, regulatory affairs , and medical device compliance. + **Post-Market Surveillance:** ... is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables...+ **Global Regulatory Strategy:** Develop and execute regulatory strategies for software-enabled medical devices… 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. ... 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)
- …. 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 (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
- 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
- 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 ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...the treatment of calcified plaque. The **Senior Director, International Regulatory Affairs ** , works closely and partners… more
- Abbott (Santa Clara, CA)
- …and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support… 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
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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
