- 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 (Sylmar, CA)
- …for new and existing medical device products. Coordinates with Engineering, Marketing, Clinical Research, and Regulatory Affairs to define product ... Gathers input for labels and IFUs from Engineering (Manufacturing, Packaging, etc.), Marketing, Clinical Research, and Regulatory Affairs (RA) to define… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Specialist** creates, evaluates and completes regulatory tasks related to worldwide product registration ... + Bachelor's Degree (BA/BS) from four-year college/university + 2+ years of regulatory affairs experience in medical devices or other regulated industry,… more
- IQVIA (Columbia, MD)
- MCRA an IQVIA business is seeking an Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions ... Clinical Testing + Manage junior members of MCRA's regulatory department. + Assist in business development functions (ie,...current agency experience is required. + 7+ years of regulatory affairs experience required. + 4+ years… more
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with...claims, while maintaining current product registrations + Assess proposed pre- clinical , clinical , and manufacturing changesfor regulatory… more
- Abbott (San Diego, CA)
- …mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our **San Diego, CA** ... reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...and mentor regulatory professionals. **Premarket:** + Approve regulatory filing strategies based on proposed preclinical, clinical… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Specialist** is responsible for assembling CE Technical files and final review of deliverables for MDR ... + Performs special projects at the direction of the Regulatory Affairs Management. + Responsible for assembling...take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. **US Regulatory Affairs Lead -Senior Manager** **Live** **What you will do** Let's do ... with a focus on patient safety + Represent regional regulatory affairs as a member of the...Group (LWG), and/or Regional Teams + Plans and manages regulatory submissions (eg clinical trial and marketing… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out ... regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Hologic (Marlborough, MA)
- Manager, Global Regulatory Affairs Marlborough, MA, United States The Manager, Global Regulatory Affairs will support leadership, ensuring alignment, ... in a matrixed, global organization. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, Quality, and Research &… more
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