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2 days ago
We are seeking a senior professional to lead our regulatory affairs team and drive global strategies for product development, commercialization, and market expansion.
About the Role- Develop and execute regulatory strategies to support business growth and ensure compliance with international regulations.
- Manage all regulatory submissions, including CE marking, FDA 510(k)/PMA, and other global submissions, to align 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.
- 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.
- Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.
- A senior leadership role with real influence across the business.
- Competitive salary and attractive benefits package.
- An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.
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