Regulatory Affairs Manager
Our client are a leading medical technologies company now looking to recruit for a Regulatory Affairs ManagerYour Responsibilities:
- Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
- Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
- Ensure current regulations and standards are available.
- Generate and maintain the DMR/DofC.
- Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.
- Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.
- Initial review of complaints to determine and record reportability.
- Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.
- Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.
- Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.
- Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.
- Participate in Continuous Improvement activities
- Undertake any assignment or duty as required by business needs.
- Adequacy and regular review of Technical File /Risk Management in accordance with current regulations.
- Maintenance of SOPs
- University degree in a scientific / engineering subject.
- At least five to ten years experience in a regulatory or quality role for a medical device manufacturer.
- Ability to perform ISO 9001 / 13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.