Quality Regulatory Manager
Quality Regulatory Manager focuses on leading the creation, maintenance, and submission of eu technical documentation and technical files from the ground up.
What the role involves
- Leading the creation, maintenance, and submission of EU Technical Documentation and Technical Files from the ground up.
- Supporting regulatory strategy for new and existing medical devices.
- Maintain documentation in accordance with MDR (EU 2017/745).
- Coordinating regulatory submissions and product registrations in European and international markets.
- Review product changes and assess regulatory impact.
- Maintaining regulatory compliance throughout the product lifecycle.
Skills and requirements
- Degree in Engineering, Life Sciences, Medical Devices, Quality, Regulatory Affairs, or a related discipline.
- Experience participating in and leading design reviews.
- Experience scaling regulatory and quality processes to support portfolio growth.
Confirmed role details
- Participate in design reviews throughout the development lifecycle.
- Ensure Design Control requirements are effectively implemented and maintained.
Report this job
Help us keep Jobs247 accurate, safe, and useful for job seekers.
Career guide
Learn more about this role
Explore the matching JobPedia guide for deeper duties, skills, salary context, and career paths.
Search for more Quality Regulatory Manager jobs from Maclivaro Limited in Hertford, Hertfordshire, East Hertfordshire, Hertfordshire; Hertfordshire; East of England; England.