- 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
- 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
- Hologic (Newark, DE)
- … Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and ... Regulatory Affairs Specialist 4 Newark, DE,...the international regulatory affairs group to support regulatory submissions worldwide for medical devices and… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! In ... your role as a Sr. Regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… 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
- BD (Becton, Dickinson and Company) (Covington, GA)
- … Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support ... **Job Description Summary** Regulatory Affairs Specialist I, Hybrid -... Specialist I are responsible for implementation of regulatory strategies including domestic and international 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
- 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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