Job Description
Job Title: Regulatory Specialist (EU MDR)Job Description
The Regulatory Specialist (EU MDR) is responsible for supporting and executing regulatory activities required to maintain compliance with the European Union Medical Device Regulation (EU MDR 2017/745). This role will collaborate closely with cross-functional teams, including Quality, Engineering, Clinical, and Manufacturing, to ensure regulatory requirements are integrated throughout the product lifecycle. The ideal candidate has a strong working knowledge of EU MDR, technical documentation requirements, post-market surveillance, and notified body processes.
Responsibilities
+ Prepare, update, and maintain EU MDR-compliant Technical Documentation, including Risk Management Files, Biological Safety documentation, and GSPRs.
+ Support submission activities for Notified Body review, including responses to NB questions and corrective actions.
+ Maintain regulatory documentation in accordance with EU M...
The Regulatory Specialist (EU MDR) is responsible for supporting and executing regulatory activities required to maintain compliance with the European Union Medical Device Regulation (EU MDR 2017/745). This role will collaborate closely with cross-functional teams, including Quality, Engineering, Clinical, and Manufacturing, to ensure regulatory requirements are integrated throughout the product lifecycle. The ideal candidate has a strong working knowledge of EU MDR, technical documentation requirements, post-market surveillance, and notified body processes.
Responsibilities
+ Prepare, update, and maintain EU MDR-compliant Technical Documentation, including Risk Management Files, Biological Safety documentation, and GSPRs.
+ Support submission activities for Notified Body review, including responses to NB questions and corrective actions.
+ Maintain regulatory documentation in accordance with EU M...
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Submit ApplicationJob Details
- Location Centennial, CO
- Job Type Full-time
- Category other-general
- Posted Date July 27, 2026
- Application Deadline August 01, 2026