- Actalent (Lake Forest, CA)
- …for New Product Development and sustaining engineering projects - Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified ... - Strong understanding of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new...regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering,… 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)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... and approving requests for product release. + May interface directly with FDA and other regulatory agencies if so directed. + Reviews protocols and reports to… more
- Medtronic (Santa Rosa, CA)
- …negotiate submission issues with agency personnel. + Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products. + ... Product development experience + Clinical or statistical experience + Experience with FDA and international regulatory agency requirements, ISO/GHTF standards +… more
- ThermoFisher Scientific (Carlsbad, CA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
- Abbott (Pleasanton, CA)
- …for regulatory approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, company policies,… 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:** Associate Principal, Regulatory Affairs **Job Description:** Responsible for establishing and...Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU… more
- Terumo Neuro (Aliso Viejo, CA)
- …for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing,...technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU… more
- J&J Family of Companies (Irvine, CA)
- …related medical device regulatory _highly desired_ . + Working knowledge of US FDA & EU MDR regulatory requirements & processes **required** . + A ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Abbott (Alameda, CA)
- …requirements. + Complies with applicable US Food and Drug Administration ( FDA ) and international regulatory requirements, Company policies, operating procedures, ... working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site at our… more