- Actalent (Cambridge, MA)
- Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage ... and CMC leads to create content plans and submission timelines for regulatory submissions . + Organize and facilitate kick-off meetings and comment resolution… more
- University of Pennsylvania (Philadelphia, PA)
- …needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, ... planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, via electronic… more
- Teleflex (Maple Grove, MN)
- …a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and regulatory reviews of ... Regulatory Affairs Specialist **Date:** Nov 11,...product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.… more
- University of Pennsylvania (Philadelphia, PA)
- …include: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... Coordinator work includes study implementation, community outreach, document development, regulatory work, subject recruitment and enrollment, study visits and … more
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations ... Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC...health agencies in support of the CMC modules of regulatory submissions . + Keeps all stakeholders, including… more
- ThermoFisher Scientific (Suwanee, GA)
- …As a Country Approval Specialist , you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You ... provided Grow your career as a Senior Country Approval Specialist , a Feasibility Specialist , or a Site...the job (comparable to 2+ years) + Background in regulatory activities, submissions and other responsibilities as… more
- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: ... at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization...to Domestic Regulatory Projects will 1) prepare regulatory submissions , including FDA Q- Submissions ,… 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)
- Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! As a ... regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- Adecco US, Inc. (Swiftwater, PA)
- Adecco Healthcare & Life Sciences is hiring a contract hybrid Regulatory Affairs Specialist for our Pharmaceutical Manufacturing partner in Swiftwater, PA. The ... upon meeting eligibility criteria Overview of the Position The Regulatory CMC Specialist will work closely with...CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submissions * Coordinates… 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
- MicroVention, Inc. (Aliso Viejo, CA)
- …the regulatory submission or complete submission. + Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the ... Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - United States… more
- Integra LifeSciences (Braintree, MA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Aid Supervisor in the development of US and ... possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level...draft submissions under supervision. Ensure timeliness of regulatory submissions according to business needs. This… 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
- ConvaTec (NJ)
- …reach millions more. Join us on our journey to #ForeverCaring as a Senior Regulatory Affairs Specialist , and you'll drive progress that really means something. ... In this role as a Senior Regulatory Affairs Specialist at Convatec, you will...and Responsibilities** : + Preparation and submission of submit regulatory dossiers (US FDA 510(k) submissions ; EU… more
- Abbott (Pleasanton, CA)
- …departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions , including European Dossiers, Premarket Notifications, ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:** Oct 23, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... 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
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development ... + Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions /dossiers (eg, 510(k), IDE, PMA, Technical Files). +… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- … is responsible for the preparation of strategies for moderately to highly complex regulatory submissions required to market new or modified medical devices and ... + Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions /dossiers (eg, 510(k), IDE, PMA, Technical Files). +… more