- Meta (Burlingame, CA)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … 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
- 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
- Kelly Services (South San Francisco, CA)
- …Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years of pre-market regulatory ... **Kelly(R) Science & Clinical** is seeking a Regulatory Affairs Manager for a direct-hire...laboratory automation and software / hardware components of IVD medical devices . + Strong communication skills, both… more
- Abbott (Alameda, CA)
- …on product lifecycle planning and regulatory requirements for Class II software medical devices + Assess the acceptability of documentation for medical ... 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)
- …a robust, scalable digital QMS tailored for Software as a Medical Device (SaMD) in a regulated environment. + Regulatory Strategy: Develop and execute ... is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables...MDR/IVDR. + Successful track record of preparing and submitting regulatory dossiers for medical devices ,… more
- Abbott (Pleasanton, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Abbott (Alameda, CA)
- …on product lifecycle planning and regulatory requirements for Class II software medical devices . Assess the acceptability of documentation for medical ... 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 of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment experience ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....products. Manage staff whose team is responsible for filing Medical Device Reports to the FDA (US),… 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
- Ascendis Pharma (Palo Alto, CA)
- … affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, ... we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned… 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 ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations**...work experience + Minimum 8 years' experience in the medical device industry, with 5 of those… more
- Abbott (Alameda, CA)
- …years' experience in regulatory affairs . + Experience working with Medical Devices , software, or combination products. + Experience working in supporting ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in...submissions (PMA, IDE, 510(k)) for Class II, and III medical devices or EU Technical Files or… more
- BeOne Medicines (San Mateo, CA)
- …Assurance + Clinical Operations + Pharmacovigilance + Clinical Business Operations + Biometrics + Medical Monitors + Regulatory Affairs + Interacts with all ... of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. + Excellent English language… more
- BeOne Medicines (San Mateo, CA)
- …formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual… more
- Abbott (Livermore, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO...and get on with their lives. This position provides regulatory compliance leadership for the business, ensuring the policies,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with colleagues in other functional areas throughout Gilead. Requirements: + 3+ years Medical Affairs ( medical device /pharmaceutical industry), managed ... with global and US TA MA, Managed Markets, Value and Access, Commercial and Government Affairs , develop Medical Affairs strategies and POAs to ensure that… more