The client is a people focused healthcare business. Founded in 1974, they have a successful track record as a manufacturer of high-quality medical devices. Based in Co. Down, greater Belfast area. They have an immediate requirement for a Regulatory Affairs Manager to join their established clinical manufacturing facility.
Reporting to the Head of Clinical and Regulatory Affairs this is an exciting opportunity to play an important role in a growing R&D team. Expansion and diversification of our product portfolio necessitates a dedicated Regulatory Affairs Manager to support the team in developing innovative medical devices. Working closely with our Innovation, Development and Industrialisation teams, you will be responsible for providing training and education to R&D personnel and ensuring overall Regulatory compliance.
- Degree level qualification (or equivalent)
- Regulatory Affairs experience within Medical Device Industry
- Experience in MDD/MDR, ISO10993, ISO13485 and ISO14971
- Ability to demonstrate regulatory knowledge in Class I and Class IIa of medical devices
- Experience in conducting risk assessments
- Experience in conducting internal and external audits
- Experience of dealing directly with Notified bodies and Competent Authorities