Medical Device Regulation Specialist
1 month ago
About the Company:
Stirling Q&R is a leading provider of medical devices, committed to delivering high-quality products that meet the needs of our customers. We are seeking a highly skilled Regulatory Affairs Manager to join our team, contributing to our mission of excellence in regulatory compliance and product development.
Job Description:
- 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 £100,000 - £130,000 per annum, depending on experience.
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