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