Regulatory Affairs Director Role
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We are seeking a seasoned Regulatory Affairs expert to join our executive team and define the company's global regulatory strategy.
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* You will be responsible for developing and driving 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.
* Maintain knowledge of 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.
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About You:
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* 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.
* Exceptional leadership, communication, and stakeholder management skills.
* Comfortable operating in a fast-paced, high-growth, entrepreneurial environment.
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What We Offer:
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* A senior leadership role with real influence across the business.
* An attractive benefits package.
* The chance to be a key architect of the company's regulatory success during an exciting growth phase.
* An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.