- Medtronic (Lafayette, CO)
- …Mission is to alleviate pain, restore health, and extend life for patients worldwide. As a Regulatory Affairs Project Specialist , you will play a crucial ... by assessing changes to existing medical devices and ensuring all necessary regulatory actions are executed. Your responsibilities will include evaluating the impact… 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 ... support through the product life cycle on product project teams (eg, developing regulatory strategies, timeline...with software and capital systems is a plus. + Regulatory Affairs Certification (RAC) desired At… more
- Bausch + Lomb (Denver, CO)
- …preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics ... labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key...and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative… more
- Sumitomo Pharma (Denver, CO)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies...quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the… more
- Danaher Corporation (Boulder, CO)
- …reports to the Sr Manager, Quality Systems and is part of the Quality and Regulatory Affairs group located in Boulder Colorado and will be an on-site role. ... which makes everything possible. The Sr Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining the… more