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EU MDR Strategist

3 weeks ago

Bradford, Bradford, United Kingdom Clinical Selection Full time

**Job Summary:** We are seeking a highly experienced EU MDR Strategist to join our regulatory team at Clinical Selection. As a key member of our team, you will be responsible for ensuring the compliance of our medical devices with EU MDR and global regulations.

The ideal candidate will have a strong understanding of EU MDR and international medical device regulations, as well as excellent project management skills and the ability to handle multiple priorities. You will be responsible for preparing and submitting regulatory documentation, developing and implementing regulatory strategies, and maintaining compliance with medical device regulations throughout the product lifecycle.

We offer a competitive salary package, including a base salary of £45,000 - £60,000 per annum, plus benefits such as pension scheme, life insurance, and annual leave. If you are passionate about regulatory compliance and enjoy working in a collaborative environment, we would like to hear from you.

About the Role:

  • Develop and implement strategies for timely approvals, aligning with both U.S. and international requirements.
  • Maintain compliance with medical device regulations, standards, and guidance documents throughout the product lifecycle.
  • Prepare and submit regulatory documentation for new products, modifications, and renewals, including CE Marking, 510(k), PMA, and international submissions.
  • Collaborate with Quality Assurance to ensure compliance with ISO 13485, 21 CFR Part 820, and other standards.

About Us:

Clinical Selection is a forward-thinking organization that values its employees' contributions to its success. We offer a supportive work environment, opportunities for professional growth, and a comprehensive benefits package.

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