The Role:
* 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.
Key Responsibilities
We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join our executive team. This is a key role where you will define and lead our global regulatory strategy, ensuring successful approvals and market access as our business scales rapidly.
As a member of our senior leadership team, you will play a critical role in shaping our regulatory approach and driving growth across multiple geographies. Your expertise in preparing and leading regulatory submissions for Class II/III devices will be essential in navigating complex regulatory landscapes and achieving successful market access.
You will have a strong understanding of the global regulatory environment, including emerging markets, and be able to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills are also essential in this role.
Requirements
* 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).
* A 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.
About You
We are looking for a highly experienced and skilled professional who can drive our regulatory strategy and lead our team with confidence. If you have a proven track record in regulatory affairs and a passion for leading high-performing teams, we would love to hear from you.