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Regulatory Affairs Lead

2 months ago

Cardiff, Cardiff, United Kingdom Stirling Q&R Full time

Job Summary:

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Stirling Q&R. This is an exciting opportunity for a seasoned professional with extensive experience in regulatory affairs within the medical device industry.

About the Role:

  • Lead the company's transition to EU-MDR requirements, ensuring compliance with complex regulations and guidelines.
  • Manage a team of UK staff, providing guidance and support to ensure seamless execution of regulatory strategies.
  • Develop and maintain regulatory knowledge of European, FDA, and country-specific regulations, staying up-to-date with changing standards and regulations.
  • Serve as a deputy Person Responsible for Regulatory Compliance (PRRC), overseeing continuous improvement processes for product quality and regulatory compliance.

Requirements:

  • Advanced degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Life Sciences).
  • Extensive experience in regulatory affairs within the medical device industry.
  • In-depth knowledge of EU-MDR and FDA regulations.
  • Strong leadership and team management skills.
  • Excellent communication and interpersonal skills.

Salary: The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience.