Regulatory Affairs Specialist

This role will see you take responsibility for ensuring ongoing regulatory compliance within the UK and Irish markets. You will stay up to date with evolving regulatory requirements, interpreting changes and ensuring they are effectively implemented across the business. A key aspect of the position will involve supporting Field Safety Corrective Actions, working closely with commercial and internal support teams to ensure timely and compliant execution.

You will act as a primary contact for Competent Authority interactions, managing queries and maintaining robust regulatory documentation to support reporting requirements. In addition, you will provide practical guidance to sales teams on complaint handling and product return processes, helping to ensure adherence to both regulatory standards and internal procedures.

The position will also involve supporting product registration activities and advising on “placing on the market” requirements, offering market-specific regulatory insight where needed. You will handle a range of regulatory documentation requests from customers, tender teams, and internal stakeholders, coordinating with relevant departments to ensure accurate and timely delivery.

The ideal candidate will have prior experience within medical device regulatory affairs and a strong understanding of compliance requirements in the UK and Ireland. You will bring excellent organisational and problem-solving skills, with the ability to manage multiple priorities effectively. A high level of attention to detail, strong communication skills, and confidence working both independently and collaboratively are essential, along with solid proficiency in Microsoft Office tools, particularly Excel.

This is a fantastic opportunity for a motivated regulatory professional to join a forward-thinking organisation in a role that offers both responsibility and exposure across key regulatory activities, all within a supportive and quality-focused environment.