Our market leading MedTech client is looking for a Regulatory Affairs Engineer to lead the regulatory function, working as part of the European team to support the company globally in delivering their products in a highly regulated environment. This critical role will encompass a broad responsibility of tasks including working closely with manufacturing, supply chain, R&D and engineering teams.
The key responsibilities include:
- Review labelling & promotional material
- ReGain market access for regulated products
- Prepare responses on all governing agency actions
- Rpresent RA in new product development
- Work on continuous improvement in the regulatory function
The right candidate for this role will have the following background:
- Extensive experience in regulatory affairs within a MedTech environment
- Previous experience in product submission strategies
- Previous experience working in a cross-functional environment, liaising with QA, Compliance and Auditing
- Master of Science or equivalent engineering degree
This is a unique opportunity to work for a market leader and gain experience working on a broad range of dynamic products.