- Abbott (Alameda, CA)
- …recognized as an expert and resource within the department, leading successful regulatory submissions and interactions with regulatory agencies while ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in Alameda, CA...related discipline + Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical… more
- Abbott (Alameda, CA)
- …presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions . This is a broad scoped position with strong ... requests for product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as identified… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May 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
- J&J Family of Companies (Santa Clara, CA)
- …Regulatory Agencies and Notified Body + Support publishing of worldwide regulatory submissions in compliance with geography-specific regulatory ... requirements + Support verification and quality review of submissions and other responses to regulatory agencies + Track and support original and renewals of… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... international product submissions + Full knowledge and understanding of global regulatory requirements for new products or product changes + Full knowledge of… more
- Merck (San Diego, CA)
- …Regulatory Compliance, Regulatory Reviews, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions **Preferred Skills:** ... advisory committee meetings and may include a speaking role. + Coordinate regional regulatory strategy and submissions through collaboration with Regulatory … more
- Abbott (Alameda, CA)
- ….. The individual has department level influence with experience in global regulatory submissions and on-market changes, and is generally recognized as ... life Sciences, Biology (or equivalent vocational qualifications) . Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... used with monitoring systems. **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to provide input on … more
- Abbott (Santa Clara, CA)
- …clinical documentation for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact of changing ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our… more