We have a unique opportunity to work for a fast-growing medical device company, working on global projects across all device ranges, including ongoing clinical trials for class III devices. Our client provides a broad and expansive portfolio of critical care, surgical and medical devices. They have a very strong presence in the UK and are expanding rapidly in both Europe and the US.
Our client is looking for a Regulatory Affairs Senior Associate to support the company’s growth and take responsibility for all aspects of the company’s regulatory affairs. The position reports directly to the Head of Regulatory & Quality Affairs and has 2 direct reports, both at Associate level.
The main responsibilities in the role will include:
- MDR management
- EU and 510k filings
- Labelling & literature review
- Writing technical files
- Maintaining MHRA records
- People leadership
The right candidate for this role will have previous RA device experience, with a good MDR knowledge and experience in EU filings.
Our client offers good homeworking flexibility and great career progression potential as the company continues to grow. They are looking for a progressive person who will lead by example, is happy to mix in with the team and get exposure to a broad range of activities. For the right candidate, this unique opportunity can really accelerate a career and gain valuable global exposure.