Our client, a global Medical Device manufacturing company specialising 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. 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 maintain EU, US, and UK device certifications and market clearance.
* Regulatory assessment of changes to devices, processes, supply chains, 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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