Regulatory Affairs Director Opportunity
Unlock a senior leadership role with real influence across the business.
* Develop and execute global regulatory strategies to drive product development, commercialization, and market expansion activities.
* Manage all regulatory submissions (CE marking, FDA 510(k)/PMA) ensuring alignment with commercial and operational timelines.
* Serve as primary liaison with regulatory authorities representing the company in all regulatory interactions and negotiations.
* Lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
* Monitor evolving regulatory requirements to ensure proactive compliance across multiple geographies.
* 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
* 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.
* Comfortable operating in a fast-paced high-growth entrepreneurial environment.
What's on Offer
* The chance to be a key architect of the company's regulatory success during an exciting growth phase.
* A competitive salary equity participation and an attractive benefits package.
* An entrepreneurial high-energy culture with a leadership team known for successful start-up growth and exits.