- 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 ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- Abbott (Santa Clara, CA)
- …business units that Leveraged Services team supports. **The Opportunity** The **Senior Manager Regulatory Affairs ** will work for our Global Regulatory ... for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may analyze broad scope implications... and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our Alameda, ... As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- Caldera Medical (Westlake Village, CA)
- Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake Village, California Sponsorship is not available for this role Caldera Medical's Mission - To Improve ... Suite proficiency (eg Microsoft Word, Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Required Knowledge, Skills and Abilities:… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine...applicable reports and ensure appropriate responses are submitted to regulatory authorities + Evaluate proposed preclinical, clinical … more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support... review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 5+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Specialist Regulatory Affairs , you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with ... required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory...**About You:** + This position is specifically focused on regulatory affairs for Software as a Medical… more
- Abbott (Sylmar, CA)
- …in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs , engineering, or medical fields. + 1+ ... guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory...year of Regulatory Affairs or Quality experience within Medical… more