- 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
- 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
- West Pharmaceutical Services (Exton, PA)
- …Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. ... Senior Specialist , Regulatory Affairs - Medical Device...+ Author and review US, EU, and additional international submissions with guidance for new products and product changes… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary The...documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions , continuing… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist , Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date: Aug 9, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... environment and planet through our sustainability efforts. **Job Summary** The Sr. Specialist , Regulatory Affairs evaluates supplier regulatory declarations… more
- Canon USA & Affiliates (Harrisburg, PA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist ... handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. **RESPONSIBILITIES** + Remote position, **west… more
- Globus Medical, Inc. (Audubon, PA)
- …of clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with ... and regional registration requirements. Compiles all materials required in submissions , license renewal and annual registrations. Recommends changes for labeling,… more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist -CC to facilitate, with minimal supervision ... and process, with minimal supervision , all initial oversight submissions for regulatory documentation through the IRB,...all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is expected to… more
- ARAMARK (Philadelphia, PA)
- **Job Description** The Global Risk and Insurance Specialist provides technical and analytical support on the procurement and management of Aramark?s global ... insurance programs. Individual will prepare timely and accurate underwriting submissions and support the administration and issuance of insurance documentation.… more
- City National Bank (Harrisburg, PA)
- *COMMAND CENTER SPECIALIST * WHAT IS THE OPPORTUNITY? The Command Center Specialist will monitor production, quality, and timeliness of workflow of Residential ... implement policies for uniformity and quality standards, and ensure compliance to regulatory requirements. As the Subject Matter Expert, they will conduct root cause… more