Regulatory Affairs Specialist - Tutbury
1 day ago
Job description
Cure Talent are delighted to be partnered with a growing, global medical device manufacturer recognised for its diverse product portfolio and international reach.
With products distributed into over 100 countries, the organisation continues to expand its regulatory capability to support global compliance and market growth.
We have an opportunity for a Regulatory Affairs Specialist to join the team with a clear focus on Technical Documentation creation and maintenance under EU MDR and other applicable global regulations.
As the Regulatory Affairs Specialist, you will take ownership of authoring and reviewing Technical Files, ensuring documentation clearly demonstrates compliance with regulatory requirements.
You will work cross-functionally with Design, Quality and Regulatory colleagues to support ongoing registrations, product updates and continuous improvement across the portfolio.
To be successful as the new Regulatory Affairs Specialist, you will bring proven experience creating Technical Documentation within a medical device environment.
You will have strong working knowledge of EU MDR requirements and understand how to structure and evidence compliance through risk management, usability and clinical evaluation documentation.
You will be comfortable managing your own workload, working independently and engaging with stakeholders to ensure regulatory standards are consistently met.
Key ResponsibilitiesAuthor and review Technical Files in line with EU MDR and relevant international regulations.
Develop and maintain supporting documentation including risk management, usability and clinical evaluation content.
Provide regulatory input to internal stakeholders across design, quality and commercial teams.
Support global registrations and ongoing lifecycle maintenance activities.
Contribute to regulatory process improvements and documentation standards.
Experience and Skills Required
Experience working with Class I or higher medical devices.
Strong knowledge of EU MDR and Technical Documentation creation.
Experience supporting risk management and clinical documentation.
High attention to detail and strong organisational capability.
Ability to operate independently within a fast-paced regulatory environment.
Familiarity with UK MDR 2002, EU Machinery Directive, RoHS, REACH, post-market surveillance or usability engineering would be advantageous.
This is an opportunity to join a global medical device organisation where regulatory documentation and compliance delivery play a central role in continued international growth.
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