- Medtronic (Irvine, CA)
- …of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling , or an advanced ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… more
- Hologic (Newark, DE)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States United States **Join us as a Regulatory Affairs ... You will provide expertise in sustaining work, supporting product changes, labeling updates, and regulatory process enhancements for both established… more
- Danaher Corporation (New York, NY)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I ... for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I...Health Canada filings, and Technical File authoring. + Provide regulatory guidance on product labeling , marketing materials,… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team... guidance throughout the product lifecycle, including development, planning, labeling , and claims, while maintaining current product registrations +… 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 ... Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine… more
- Nestle (Arlington, VA)
- …databases and documentation systems, develop raw material specification data to support labeling compliance, and assess the impact of regulatory changes on ... the product portfolio. + Prepare scientific and regulatory dossiers and registrations required by regulation or Nestle...labeling as well as early warning of potential regulatory events and potential impact to the Nestle portfolio.… more
- Merck (De Soto, KS)
- …in regulatory matter(s), such as but not limited to labeling , facility documents, relative Potency assays, antigen overages, licensure processes, permits, ... **SUMMARY OF POSITION** This position is responsible for ensuring regulatory filings of animal health products in pursuance of...with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in… more
- Edwards Lifesciences (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... 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) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a crucial role in supporting Medication ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
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