- Dentsply Sirona (Charlotte, NC)
- …**Make a difference** -by helping improve oral health worldwide. Sr. Regulatory Affairs Specialist + Leads regulatory submissions to obtain and maintain ... preferably in the medical device industry + Experience with leading regulatory submissions and documentation, including 510(k) submissions and CE marking… more
- Teleflex (Morrisville, NC)
- …Senior Regulatory Affairs Specialist will develop strategies and regulatory submissions for Material Cost Improvement Projects (CIP) and address issues ... Sr Regulatory Affairs Specialist **Date:** Aug 25, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition… more
- University of Pennsylvania (Philadelphia, PA)
- …region. Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... coordinator work includes study implementation, community outreach, document development, regulatory work, subject recruitment and enrollment, study visits and … more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting...PMA submissions a plus + Experience assessing regulatory … more
- Teleflex (Morrisville, NC)
- …a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues ... Regulatory Affairs Specialist **Date:** Aug 11,...for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance. * Review and… more
- Fresenius Medical Center (Lexington, MA)
- …and Engineering Change Orders. Specific duties include: * Prepares and submits US regulatory submissions including 510(k)s, IDEs, and pre- submissions . * ... Senior Regulatory Affairs Specialist , NxStage Medical, Inc.,...Prepares and submits international regulatory submissions , including but not limited to Canada and Europe… more
- Medtronic (Mounds View, MN)
- …strategies. + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and ... will be base in Mounds View, MN The **Associate Regulatory Affairs Specialist ** will provide regulatory...complaints, and product failure analysis. + Prepare and track submissions for FDA and global regulatory agencies,… more
- Caldera Medical (Westlake Village, CA)
- …Life for Women! Message from the Hiring Manager: In your role as a Sr. Regulatory specialist , you will develop and implement medical device regulatory ... Sr. Regulatory Affairs Specialist 100% ONSITE in...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused...line extensions. The incumbent may also develop and implement regulatory strategies to support new 510(k) submissions ,… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more