- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor ... risk for wearable-based health technology. + Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric… more
- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Abbott (Santa Clara, CA)
- …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,...+ In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485, GDPR) relevant to software products,… more
- Abbott (Santa Clara, CA)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Abbott (Alameda, CA)
- …product post-marketing approval requirements as needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for international ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Terumo Neuro (Aliso Viejo, CA)
- …approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy...Strong technical writing skills as evidenced by successful US FDA Class II / III medical device submissions, EU… more
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …Preferred Qualifications: * Experience working with radiopharmaceuticals and knowledge of FDA regulatory pathways. * ACRP certification, expertise in ... Preferred qualifications * Experience working with radiopharmaceuticals and knowledge of FDA regulatory pathways. * ACRP certification, expertise in … more
- Sumitomo Pharma (Sacramento, CA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product ... + Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +...or more of FDA submissions and international regulatory compliance. + Lead Auditor certification preferred. + Strong… more
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