Regulatory Affairs Director Role
Regulatory Affairs Director Job Description
This is an exceptional opportunity for a seasoned Regulatory Affairs professional to join our team as a Director. We are seeking a strategic thinker with outstanding leadership and communication skills to drive regulatory success.
* Develop, implement, and execute global regulatory strategies that support product development, commercialization, and market expansion activities.
* Lead the preparation and submission of regulatory filings (CE marking, FDA 510(k)/PMA) 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, lead, and motivate 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.
* Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
* Support due diligence and partnership activities through regulatory assessments and strategy development.
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).
* A strong understanding of the global regulatory environment, including emerging markets.
* The 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.
* A degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.
What's on Offer
This is an exciting opportunity to join our dynamic team and contribute to the company's growth and success. As a Regulatory Affairs Director, you can expect:
* A senior leadership role with real influence across the business.
* 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.