Job Title: Regulatory Affairs Director
This is a key role where you will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the 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 the company in all regulatory interactions and negotiations.
* Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
* Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies.
You will collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
About You
We are looking for a candidate with 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.
Candidates should have a degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field and be comfortable operating in a fast-paced, high-growth, entrepreneurial environment.