Regulatory Affairs Director
We are seeking a highly experienced Regulatory Affairs professional to join our team as a Director.
About the Role
This is a key leadership position where you will define and execute our global regulatory strategy, ensuring successful approvals and market access as our business scales rapidly.
* Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
* Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
* Serve as the primary liaison with regulatory authorities, representing us in all regulatory interactions and negotiations.
Requirements
To be successful in this role, you will need:
* A minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
* Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential).
* Strong understanding of the global regulatory environment, including emerging markets.
* Ability to think strategically while executing detailed regulatory plans.
* Exceptional leadership, communication, and stakeholder management skills.
What We Offer
In return for your expertise, we offer:
* A senior leadership role with real influence across the business.
* Competitive salary and attractive benefits package.
* An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.