- 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
- 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
- Abbott (Pleasanton, CA)
- …**Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart... regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . +… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … 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
- 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …apply global IVD regulatory requirements. + Experience with IVD and/or Medical device country registration/submission. + Familiarity with ISO 13485/900, EU ... **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our ...and work experience. + +/- 17 years in the medical device , diagnostics, biologics, or pharmaceutical industry,… 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 (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...regulatory requirements for medical devices … 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
