- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% ... solutions that make a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participate in teams for sustaining products to provide input on global regulatory requirements. + Support regulatory submissions , filings, and responses ... device (SiMD) and software as a medical device (SaMD), preferred. + Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for software-based… more
- bioMerieux Inc. (Salt Lake City, UT)
- …compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager. 8. Participate in the ... with minimal oversight. 3. Participate in the preparation of regulatory submissions (US, EU, Global) and additional... topics. 11. Lead projects with some guidance from senior regulatory employees/managers 12. Ensures accurate population… more
- bioMerieux Inc. (Durham, NC)
- …compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager. May begin to mentor ... company policy and procedures. Participate in the preparation of regulatory submissions (US, EU, Global) and additional...to lead on their own with some guidance from senior regulatory employees/managers. Ensures accurate population of… more
- Johns Hopkins University (Baltimore, MD)
- …of Research & Translation (ORT) is seeking a Grants & Contracts Specialist who will work directly with project PIs, Co-PI's/Co-I's and finance/administrative staff. ... and financial status reporting processes. The Grants & Contracts Specialist will provide entry level sponsored funds management for...management under the direction and oversight of a more senior member of the team. Types of sponsored awards… more
- Parexel (Washington, DC)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a ** Senior Physician in ... reports, Investigators Brochures, and other related documents + Contribute to regulatory agency submissions (Investigational new drug applications, new drug… more
- City of Concord (Concord, NH)
- …Assistant City Planner - Community Planning, Assistant City Planner - Zoning, Senior Planner, Administrative Specialist , Planning and Zoning Inspector and Trail ... the preparation and implementation of the City's Master Plan as well as regulatory amendments (see job description for a full list of duties and responsibilities).… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on ... complex global regulatory strategies and preparation of regulatory submissions required to market medical devices...devices in the US The Senior RA Specialist will also support related regulatory affairs… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …become your best self. Become a **maker of possible** with us. **Job Summary** The Senior Specialist , Regulatory Affairs plays a key role in ensuring Becton, ... teams for our China regional market. The **Bilingual Mandarin Chinese and English** ** Senior Specialist , Regulatory Affairs** plays a critical role in… more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% ... solutions that make a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies,… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Start-Up Specialist Senior -CC Job Profile Title Clinical ... ACC Regulatory Affairs Office seeks a full-time Senior Regulatory Affairs Start-Up Specialist ... will independently prepare and process all initial oversight submissions for regulatory documentation through the IRB,… more
- Pentax Medical (Montvale, NJ)
- …provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are ... in shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist :...biocompatibility requirements + Proven track record in writing major regulatory device submissions (ie 510(k)s), with the… more
- Abbott (Sylmar, CA)
- …fingersticks. **The Opportunity** Our location in Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist -China. As a Senior ... matters. What You'll Work On * As the Senior Specialist in Regulatory Affairs...submissions experience. + 4 or more years direct regulatory affairs submissions experience, submission experience to… more
- Medtronic (Santa Rosa, CA)
- …position will be based in Mounds View, MN or Santa Rosa, CA. The ** Senior ** ** Regulatory Affairs Specialist ** will support our innovative Transcatheter ... II and Class III) to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates...and negotiates their approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment… more
- West Pharmaceutical Services (Exton, PA)
- Senior Regulatory Affairs Specialist ...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist , Regulatory Affairs, Medical is responsible for influencing department… more
- Abbott (Pleasanton, CA)
- …from diagnosis to monitoring and treatment. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions , including European Dossiers, Premarket Notifications,… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** in **Redmond, Washington.** ... pathways, and compliance activities. + Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is ... responsible for preparing and managing regulatory submissions to support the global commercialization...us. **Position Summary:** We are seeking a Sr. International Regulatory Affairs Specialist to join our … more
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