Website SEDA Talent
Regulatory Affairs Manager
12 Month Fixed Term Contract
Coleraine (hybrid working available)
Our client, based in Coleraine, with locations across the UK, have retained SEDA Talent to recruit a Regulatory Affairs Manager to join their team. You will be joining a company that has continued to grow every year, with plans of more acquisitions and expansions, that are also a local success story.
This is an ideal opportunity for a person that has a strong back in quality or compliance gained in the medical devices industry that want to continue to grow and learn.
The Role
Reporting to the Head of Clinical & Regulatory Affairs, the Regulatory Affairs Manager will be responsible for providing Regulatory direction and guidance within the Coleraine site.
The Regulatory Affairs Manager role is key to the success of the regulatory and quality strategy, ensuring the development of regulatory strategies supporting New Product Development (NPD) and Notified Body communications / submissions.
The Regulatory Affairs Manager will act as the Person Responsible for Regulatory Compliance (PRRC) for the business.
Ideal Candidate
• Educated to degree level in life science, engineering or another relevant scientific discipline.
• Significant professional experience in regulatory affairs or in quality management systems relating to medical devices, ISO Standards and FDA CFR in a continuous improvement environment.
• Full UK Driving Licence.
A competitive salary + benefits is on offer for the right candidate. For further details please apply with your CV and our team will respond.
