Regulatory Affairs Manager

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 listing

Skills:

• 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 recalls

Qualifications

• 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

To find out more about Real, please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales