Regulatory Affairs Strategist
We are seeking a highly experienced and skilled Regulatory Affairs Strategist to join our executive team. 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.
Key Responsibilities:
* 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.
* 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. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.
What We Offer
A senior leadership role with real influence across the business. 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.