Regulatory Affairs Manager

Our client, a global Medical Device manufacturing company specializing in Fem Tech, is looking for a Regulatory Affairs Manager to join an exciting team reporting to the Director of Regulatory Affairs. The company produces equipment, consumable medical devices, and general laboratory equipment. This is a cross-functional role where the chosen candidate will work with internal and international teams/departments.

The company will offer hybrid or remote working for those further away if needed.

Summary:

• The Regulatory Affairs Manager is responsible for regulatory strategy to attain and maintain EU, US, and UK device certifications and market clearance.
• Regulatory assessment of changes to devices, processes, supply chain, and regulations, and resultant notification and re-registration activities.
• Proactively monitoring changes in EU and UK medical device regulations, and sharing or providing training to global Regulatory Affairs teams, commercial, distribution, and service teams.
• UKCA mark compliance and MHRA registration and listing.

Skills:

• Management, support, and development of RA team members responsible for creation and maintenance of Technical Documentation Files and Device History Files.
• The Regulatory Affairs Manager will manage RA projects and define strategy for new product development, maintenance of legacy device portfolio, acquisitions, etc.
• Proactively monitor changes in regulations and share or provide training to Regulatory Affairs teams, commercial, distribution, and service teams.
• Manage the creation and maintenance of Technical Documentation Files.
• Ensure effective project management for product certification, registration, and re-registration.
• RA strategic planning and assessments.
• Regulatory representative and advisor for new product development at the concept phase.
• Develop business relationships with key stakeholders (internal/external).
• Achieve measurable results in all certifications and ongoing submissions.
• The Regulatory Affairs Manager will participate in training and attend conferences and meetings.
• Provide regulatory support during surveillance audits as necessary to maintain international licenses, registrations, and certification.
• Lead Regulatory support for closure of non-conformances raised at internal or external audits.
• Regulatory Lead for QMS documentation, change control, and design and process deviation management.
• Regulatory Lead point contact for global vigilance, FSCAs, and recalls.

Qualifications:

• Knowledge of medical device requirements primarily for US and EU markets.
• Ability to read and interpret medical device regulations and requirements.
• Ideally a degree in Life Science, Engineering, Compliance, etc., OR equivalent practical expertise.