- Dentsply Sirona (Sarasota, FL)
- …someone that is near the Sarasota, FL location.** **Job Summary:** **The Senior Regulatory Specialist is a contributing member of cross-functional teams in ... approvals for medical devices + Prepares and submits international regulatory submissions to obtain and maintain...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline **Years… 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.** ... As part of the Medical Regulatory Affairs team, you will work with... classification and jurisdiction. + Determine requirements (local, national, international ) and options for regulatory submission, approval… more
- Abbott (Pleasanton, CA)
- …people with diabetes from routine fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our team in the ... worldwide registration. Responsibilities: + Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist ** to join our team on-site in ... guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. + Compile, prepare, review and submit medical… more
- Danaher Corporation (Richmond, IL)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Regulatory Affairs Specialist for Leica ... Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills. This position reports to the Director, Quality… more
- embecta (Parsippany, NJ)
- …market new or modified devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with regulations and alignment with the ... objectives of the business. This role will also represent regulatory affairs and provide leadership across multiple project development teams by interpreting and… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …with us. **Job Responsibilities:** _(Primary Duties, Roles, and/or Authorities)_ + Represents Regulatory Affairs on product development teams to support new ... Requirements:** + Bachelor's degree or higher + 6-8 years' Regulatory Affairs experience in the medical device...with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions + Proven experience owning and… more
- Philips (New Kensington, PA)
- The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field ... submissions, pre-sub documents, EUMDR tech files, and will contribute to international regulatory submissions. + Participate in strategic product development,… more
- BD (Becton, Dickinson and Company) (Louisville, CO)
- **Job Description Summary** The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international ... documents) + Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required + Provide technical collaborate with...with software and capital systems is a plus. + Regulatory Affairs Certification (RAC) desired At… more
- Philips (Colorado Springs, CO)
- The Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design and manufacturing changes, and ... You've acquired a minimum of 3+ years' experience in Regulatory Affairs within FDA and/or EU MDR...with FDA, EU MDR, Health Canada, and other relevant international regulatory standards, regulations, and submission paths.… more