Regulatory Compliance Manager
3 days ago
Bio Source Ltd, a leading company in the MedTech industry, is seeking a highly skilled Regulatory Manager to join their team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements and managing the technical file.
Key Responsibilities:
- Conduct internal and regulatory audits to ensure compliance with ATEX, FDA, and CE Medical Devices regulations.
- Manage the technical file and ensure it is up-to-date and compliant with regulatory requirements.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
- Develop and implement processes to ensure regulatory compliance and identify areas for improvement.
Requirements:
- Proven experience in Medical Regulator Approvals within BioTech or MedTech, with a strong background in regulatory compliance.
- Experience with internal and regulatory audits, ATEX, FDA, and CE Medical Devices.
- Strong management skills and ability to lead cross-functional teams.
What We Offer:
- A competitive salary of £50K FTE, with the option to work part-time.
- Excellent benefits package, including bonus opportunities.
- A dynamic and supportive work environment with opportunities for growth and development.
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