- Medtronic (Mounds View, MN)
- … Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. ... and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support… 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
- 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 drafts, submits and gains...Specialist drafts, submits and gains clearance for 510(k) submissions , and approval for IDE/PMA submissions to… 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
- Integra LifeSciences (Braintree, MA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development of US and International ... and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior...(510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This… more
- Eurofins (Davis, CA)
- …origin, traceability and purity of biological substances and products. Summary The Regulatory Specialist is responsible for the implementation and oversight of ... of submissions under review + Coordinate, prepare, or review regulatory submissions for domestic or international projects + Interpret regulatory rules… 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
- 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
- Actalent (Agoura Hills, CA)
- Description As a Sr. Regulatory specialist , you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure … more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
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