- 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
- Medtronic (Los Angeles, CA)
- …on meeting business objectives with excellence. From developing and authoring regulatory submissions to providing critical input on cross-functional project ... 160 countries. A Day in the Life As Senior Regulatory Affairs Specialist , you will develop and...IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting… 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
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation...Author and support 510(k), Tech File / STED File submissions as required. + Provide regulatory support… 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
- Kelly Services (Valencia, CA)
- …Affairs Specialist - Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1 year) at a ... occasional work in Burbank. If you have expertise in regulatory submissions and quality operations in the... regulatory reviews, and participating in audits. The Regulatory Specialist will also act as a… more
- University of Florida (Gainesville, FL)
- Research Regulatory Specialist -Department of Neurosurgery Apply now ... Administration Department: 29190000 - MD-NEUROLOGICAL SURGERY Classification Title: Research Regulatory Specialist Classification Minimum Requirements: Bachelor's degree… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:** Apr 9, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,...will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to… more
- Abbott (St. Paul, MN)
- …achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions , including IDE, European Dossiers, Premarket ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or… more
- J&J Family of Companies (New Brighton, MN)
- …collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and ... Description:** Johnson & Johnson is hiring for a **Sr Regulatory Affairs Specialist - Shockwave Medical** to...Canada. May require supporting international regulatory team with submissions to other geographies.… more
- Houston Methodist (Houston, TX)
- …such as DOA logs, assist with reporting RNIs, reporting deviations, perform IRB submissions , amendments. The Regulatory Compliance Specialist will be ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across… more
- Dartmouth Health (Lebanon, NH)
- …ultimately aiming to improve the turnaround time of prior approval and other regulatory submissions to NCATS. * Assists with updating, compiling, and submitting ... Overview The Quality Assurance & Compliance Specialist (QACS) of Dartmouth’s Clinical and Translational Science...position will provide targeted education on IRB and NCATS submissions that covers study design, regulatory and… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …and labels, labeling, and promotional materials. + Leads and prepares high-quality regulatory submissions such as Pre- Submissions , IDEs, 510(k)s, De ... **maker of possible** with us. **Job Overview** The Staff Regulatory Affairs Specialist is part of the...for IVD and CDx new product development, developing global regulatory strategies, submissions to FDA and an… more
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