Global Regulatory Leader

4 days ago


Mountain Ash, United Kingdom Stirling Q&R Full time
Job Summary

We are seeking a highly motivated Global Regulatory Leader to join our team at Stirling Q&R. As a key member of our regulatory and clinical leadership team, you will be responsible for leading our regulatory and clinical activities to ensure compliance with global regulations and overseeing clinical evaluations for our medical device products.

Main Responsibilities:
  • Develop and implement regulatory strategies for product approvals in various global markets
  • Manage the preparation and submission of regulatory documents to health authorities
  • Stay current with changes in regulations, particularly EU MDR, and lead company transition efforts
  • Coordinate with cross-functional teams to ensure regulatory compliance throughout product lifecycle
Clinical Evaluation:
  • Oversee clinical evaluation processes, post-market clinical follow-up (PMCF), and clinical investigations
  • Develop clinical strategies aligned with regulatory requirements and business objectives
  • Manage relationships with clinical research organizations and investigators
Leadership and Team Development:
  • Manage and develop a team of regulatory and clinical professionals
  • Provide mentorship and guidance to team members
  • Collaborate with other departments to ensure alignment of regulatory and clinical activities with overall business goals
Quality and Compliance:
  • Ensure adherence to quality management systems and SOPs
  • Participate in internal and external audits
  • Identify and address compliance issues, conducting investigations when necessary

The estimated salary for this position is $160,000 - $220,000 per year, depending on experience and qualifications.



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