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.

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