- University of Pennsylvania (Philadelphia, PA)
- …such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . A member of the Submissions team of the Specialist level in US Commercial Regulatory Affairs Operations (CRA Ops) supports ... tasks, primarily through the submission of Promotional Material to the FDA. The Submissions team member is responsible for the review and approval of submissions… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key...the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities… 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
- 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
- Medtronic (Minneapolis, MN)
- …+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg, ... a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST ** In collaboration with leading clinicians, researchers and… 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
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such ... and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of… more
- Medtronic (Minneapolis, MN)
- …to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with ... + Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg,… more
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