We are a market leading Medical Device company and due to continued growth, we have an exciting opportunity available for a Regulatory Affairs Manager to join our team in Slough.
As our new Regulatory Affairs Manager, you will be responsible for leading and managing the UK Regulatory requirements to ensure timely approvals, reporting, maintenance and compliance of legally marketed products to meet corporate objectives through the execution of sound Regulatory strategies and practices by communicating with the MHRA, business partners, customers and global colleagues.
- Registering devices with the MHRA before the devices can be placed on the market
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
- Proven experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
- Proven leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
- Experience of interpreting and implementing standards and regulations essential.
- Broad background in quality and regulatory compliance of systems and products essential.
- Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities