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Our client a global Medical Device manufacturing company specialising in Fem Tech are looking for a Regulatory Affairs Manager to join an exiting team reporting to the Director of Regulatory Affairs. The company produce equipment, consumable medical devices and general laboratory equipment. A cross functional role 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 maintaining EU, US and UK device certifications and market clearance
regulatory assessment of changes to devices, process, supply chain and regulations, and resultant notification and re-registration activities
proactively monitoring changes in EU and UK medical device regulations, and share or provide training to global Regulatory Affairs teams, commercial, distribution and service teams
UKCA mark compliance and MHRA registration and listingSkills:

Management, support and development of RA team members responsible for creation and maintenance of Technical Documentation Files, Device History Files
The Regulatory Affairs Manager will be managing 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 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 concept phase
Develop business relationship 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 recallsQualifications

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

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