**Global Regulatory Strategist Role**
We are seeking a seasoned Regulatory Affairs Leader to spearhead our global regulatory strategy, ensuring successful product approvals and market access as our business scales.
The ideal candidate will have a strong strategic vision, leadership capability, and experience in developing and executing regulatory plans for medical devices. They will be responsible for defining and driving our global regulatory strategy, managing all regulatory submissions, and serving as the primary liaison with regulatory authorities.
This is a key role where you will work closely with cross-functional teams to integrate regulatory requirements into project plans and strategic decision-making. You will also be responsible for building and leading a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
We are looking for someone with a minimum of 10 years of 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) is required. A strong understanding of the global regulatory environment, including emerging markets, is also essential.
The right candidate will have exceptional leadership, communication, and stakeholder management skills. They will be comfortable operating in a fast-paced, high-growth, entrepreneurial environment and have a degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.
About this Opportunity:
* Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities
* Manage all regulatory 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
What We Offer: A senior leadership role with real influence across the business, competitive salary, equity participation, and an attractive benefits package. If interested in discussing further, please contact us.