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Senior Regulatory Compliance Officer

2 months ago


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

About the Job:

The Regulatory Affairs Manager will play a critical role in shaping the company's regulatory strategy and ensuring compliance with relevant regulations. This is a challenging yet rewarding opportunity for a motivated and experienced professional to lead our team and drive business growth.

Key Responsibilities:

  1. Develop and maintain a comprehensive understanding of EU-MDR and FDA regulations, identifying areas for improvement and implementing changes to ensure compliance.
  2. Lead the company's transition to EU-MDR requirements, coordinating with cross-functional teams to ensure a smooth transition.
  3. Manage a team of UK staff, providing training and development opportunities to enhance their skills and knowledge.
  4. Collaborate with internal stakeholders to develop and implement regulatory strategies, ensuring alignment with business objectives.

Qualifications and Skills:

  • 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 £90,000 - £120,000 per annum, depending on experience.