As a Regulatory Affairs Manager, you will be the on-site expert on all regulatory matters. You will be responsible for co-ordinating work undertaken by other specialists, clinical writer (s) and biocompatibility consultants. Some of your key responsibilities and tasks include:
- Day to day management of a team of technical file writers who share responsibility for all technical files for the site.
- Creation and maintenance of technical files of all legal manufactured products to MDD requirements
- Updating Technical files to meet requirements of MDR
- Creation and maintenance of technical documentation to meet US FDA requirements
- Creation of RA plans for the design and development teams to support Global markets
- Assisting and ensuring devices are registered in EU/FDA and UK MHRA databases as appropriate
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising.
- Support the wider Regulatory Affairs team as required
As the ideal candidate you will have a degree in a relevant scientific discipline and a minimum of 5 years' experience in the medical devices to MDD/MDR. Working knowledge of US FDA requirements and MDSAP are essential. The ideal candidate will be Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written. Some flexibility on working hours preferred as the role will involve interaction with US manufacturing sites.
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