Regulatory Affairs and Clinical Strategist

1 month ago

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

We are seeking an experienced professional to lead our regulatory and clinical activities at Stirling Q&R. This role is crucial in ensuring compliance with global regulations and overseeing clinical evaluations for our medical device products.

Key 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 and Management:
  • 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
Team Leadership and Collaboration:
  • 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

This position offers an opportunity to play a crucial role in bringing innovative medical devices to market while ensuring patient safety and regulatory compliance. The ideal candidate will be a strategic thinker with a passion for advancing healthcare through effective regulatory and clinical management.

The estimated salary for this position is $120,000 - $180,000 per year, depending on experience and qualifications.

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