- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions (FDA, EU MDR, international). + Maintain product ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...Proven experience with 5 years or more of FDA submissions and international regulatory compliance. + Lead… more
- Abbott (Santa Clara, CA)
- …and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities + Negotiate and interact with ... and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager ** position is an onsite...+ Previous experience with PMA / IDE and international submissions + Experience with combination product and/or Class III… more
- Edwards Lifesciences (Irvine, CA)
- …submission data. Track timelines and documents milestone achievements for inclusion in regulatory submissions . Interact with regulatory agencies as part ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… 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...and SOPs + Experience working with 510k and PMA submissions The base pay for this position is $112,000.00… more
- Deloitte (Los Angeles, CA)
- …available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating submissions packages + Experience ... role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components...4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like… more
- Medtronic (Los Angeles, CA)
- …for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS) geographies. ... regulatory and quality system procedures. + Prepare regulatory submissions for new products and product...ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing… more
- Meta (Burlingame, CA)
- …device regulatory affairs or related industry 9. Experience in global regulatory submissions and product approvals 10. Experience communicating and leading ... software as a medical device direct to consumer space. You will lead regulatory strategy development, submissions , and approvals for United States and… more
- Envista Holdings Corporation (Brea, CA)
- …and literature. + Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs. + Assists with Customs requests. + Responsible for ... global submissions (as required). + Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA, HC, EU and ROW).… more
- Envista Holdings Corporation (Brea, CA)
- …and compliant product registrations. + Prepare, submit, and maintain regulatory submissions , product registrations, certifications, and facility registrations ... The ** Regulatory Affairs Specialist** creates, evaluates and completes regulatory tasks related to worldwide product registration submissions , facility… more