Medical Devices Regulatory Manager

Our Client a leader in the medical software space has an opportunity to join a fast growing team with the concentration of the role on the production of medical device technical in compliance with the medical Device Regulation and ISO 13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards.

Job Description:

• Responsibility for preparation and submissions of regulatory applications and registrations.
• Point of contact for competent authorities.
• Create, modify, and maintain device Technical Files.
• Maintain technical files according to requirements of current regulations and legislation.
• Final regulatory approval of software validation reports prior to their release.
• Regulatory subject matter expertise to support business activities.
• Manage and address any audit device technical file non-conformities.
• Ensure regular collection of evidence for the annual clinical evaluation and post market surveillance reports and create the reports, notifying the relevant authorities to any abnormal trends.
• Maintain a knowledge of the changing regulatory standards and implement the changes necessary.
• Deliver the supporting documentation required for sales frameworks and tender responses.
• Manage and support the internal and external regulatory resource.
• Working with ISO Compliance Manager to fulfil an audit schedule for medical device compliance.
• Maintain security, integrity, and the confidentiality of data.

Education and Qualifications:

• Life/health sciences-based undergraduate degree.

Knowledge and Experience:

• Technical background within Medical Devices with an in-depth understanding of the regulatory function, with good knowledge of related quality, engineering, clinical, safety, and post-market functions.
• 3+ years regulatory affairs experience within the medical device sector.
• Strong understanding of Medical Device Directive / Medical Device Regulation transition process.

Up-to-date working knowledge of:

• MDD and MDR (Class 1 & 11a devices)
• BS EN ISO 13485, 14971, 14155, 27001
• BS EN IEC 60601
• BS EN 62304
• NHS DCB0129 / DCB0160
• UK General Data Protection Regulation (GDPR)

Key Skills:

• Good working knowledge of EN 62304, having maintained electronic and software devices technical files.
• Experience in the production and maintenance of documentation supporting NHS DCB0129/0160.
• Willingness and ability to write and update regulatory and technical documentation and complete the required regulatory submissions.
• Pragmatism and responsibility to drive activities.
• Work effectively, both independently and as part of a team and develop, maintain and work to defined project plans and have a structured and methodical approach.
• Excellent verbal and written English and have reporting and presentation skills.