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Affairs Leader for Global Market Expansion
3 weeks ago
Job Title: Regulatory Affairs Director
This is a key leadership 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.
- Support due diligence and partnership activities through regulatory assessments and strategy development.
About You:
We are seeking a candidate with a minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
Required Skills and Qualifications:
- 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.
Benefits:
This is an exciting opportunity to be a key architect of the company's regulatory success during an ambitious growth phase.
You will have 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.
