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Regulatory Affairs Director

1 month ago

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

The Regulatory Affairs Manager at Stirling Q&R will oversee regulatory compliance, submissions, and strategies for medical devices. This role involves leading the company's transition to EU-MDR requirements, managing a team of UK staff, and serving as a deputy Person Responsible for Regulatory Compliance (PRRC).

Key Responsibilities
  • Develop and maintain regulatory knowledge of European, FDA, and country-specific regulations
  • Lead company transition to EU-MDR requirements
  • Coordinate and prepare regulatory submissions and strategies
  • Manage a team of UK staff
  • Act as deputy PRRC, including:
    • Developing continuous improvement processes for product quality and regulatory compliance
    • Preparing and maintaining technical documentation and EU Declaration of Conformity
    • Meeting post-market surveillance obligations
  • Identify compliance issues and conduct or direct required investigations
  • Serve as a point of contact for employees on compliance matters
  • Review and modify policies to comply with changing standards and regulations
  • Stay informed about industry trends and assess their impact on organizational processes
Requirements

Required:

  • 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
  • Ability to interpret and apply complex regulatory requirements

Desired:

  • Professional certification in Regulatory Affairs (e.g., RAC)
  • Experience with quality management systems
  • Knowledge of international regulatory environments beyond EU and US
What We Offer

At Stirling Q&R, we offer a range of benefits to our employees, including:

  • Pension Plans
  • Work From Home
  • Training & Development