- Vanderbilt University Medical Center (Nashville, TN)
- …requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...Allied health is among the fastest growing occupations in healthcare today. This area can be defined as credentialed… more
- Medtronic (Washington, DC)
- …RoHS, SCIP) + Experience in counseling on US Food and Drug Administration ( FDA ) regulatory requirements + Experience in conducting reviews of advertising and ... can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down… more
- Cordis (Irvine, CA)
- …of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical ... to remote. MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role will play a… more
- BeiGene (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- J&J Family of Companies (Titusville, NJ)
- …Qlik, Tableau, SPSS or SAS) required. Preferred: + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and ... Johnson & Johnson is currently seeking a Regulatory Operations Senior Analyst to join our Specialty...Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where… more
- Integra LifeSciences (Braintree, MA)
- …Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Begin to interact with Regulatory Body personnel under direct ... work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To...possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level role responsible… more
- Integra LifeSciences (Princeton, NJ)
- …Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with minimal supervision. ... work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To...outcomes and set new standards of care. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role… more
- Takeda Pharmaceuticals (Exton, PA)
- …**Job Description** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexington, MA or Exton, PA office. Where you ... team, you will be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and… more
- J&J Family of Companies (Raritan, NJ)
- …plans including BLA/NDAs, IND/CTAs & supplements. + Serve as primary point of contact for US FDA + Lead the regulatory response team for FDA and Health ... Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can be located in Spring...Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where… more
- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Abbott (Atlanta, GA)
- …required for product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... Abbott is a global healthcare leader that helps people live more fully...communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA… more
- Sumitomo Pharma (Columbus, OH)
- …dynamic, highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs** . The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/she...position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products.… more
- University of Pennsylvania (Philadelphia, PA)
- …addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA , via electronic means, where available and feasible. Support faculty sponsors and ... addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA , via electronic means, where available and feasible. Support faculty sponsors and… more
- University of Pennsylvania (Philadelphia, PA)
- …institutes, to ensure compliance with relevant regulations, Good Clinical practice (GCP), and FDA guidelines. The CRC B ( Regulatory Coordinator) will assist with ... The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **Senior Manager, US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA or Exton, PA** **About the ... Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal...where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion… more
- UTMB Health (Galveston, TX)
- …utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist II may also function as a Principal Investigator for extramurally funded ... reviews with that department. **SALARY:** Commensurate with experience **_Official Regulatory Statement for Healthcare jobs' Job Descriptions_** :… more
- Stryker (San Jose, CA)
- …the Point of Contact for responsible products/technical files + Author and submit electronic regulatory submissions for the FDA and Notified Body + Prepare EU ... technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and… more
- Abbott (Plymouth, MN)
- …with FDA submissions and applicable regulations. + Interfaces directly with FDA and other regulatory agencies. + Supports the product release process ... regulatory requirements + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more