Director of Regulatory Affairs

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Key responsibilities will include: • Develop and execute global regulatory strategies for new and existing IVD products. • Lead regulatory activities supporting product development, registrations, approvals and market expansion across the US, Europe and international markets. • Lead and support compliance with the EU IVDR, including technical documentation and interaction with Notified Bodies. • Act as a key point of contact with regulatory authorities, including the FDA and European Notified Bodies, managing meetings, submissions, questions and responses. • Lead the preparation, review and submission of regulatory documentation and product dossiers. • Assess regulatory risks and provide clear recommendations to senior leadership and cross-functional project teams. • Partner closely with R&D, Clinical, Quality, Operations and Commercial teams to ensure regulatory requirements are incorporated throughout product development. • Maintain regulatory compliance across the full product lifecycle, including change management, labeling and post-market requirements. • Monitor changes in global regulatory requirements and evaluate their potential impact on existing products and development programs. • Support the continued development of regulatory processes, best practices and capabilities as the organization grows. • Provide leadership and mentorship across the Regulatory Affairs function and contribute to broader organizational strategy.

We are partnered with an innovative diagnostics organization seeking an experienced Director of Regulatory Affairs to provide strategic regulatory leadership across its growing in vitro diagnostics portfolio.

This is a senior, high-impact position with responsibility for shaping and executing global regulatory strategy, supporting new product development and registrations, and ensuring continued compliance throughout the product lifecycle.

The successful individual will work closely with R&D, Clinical, Quality, Commercial and executive leadership while acting as a key regulatory representative with global health authorities.

The Opportunity As Director of Regulatory Affairs, you will take ownership of regulatory strategy across both new and existing diagnostic products, helping guide products from development through submission, approval and post-market lifecycle management.

Who You Are You are an experienced Regulatory Affairs professional with a strong background in in vitro diagnostics and a proven ability to translate complex regulatory requirements into practical commercial and development strategies.

Ideally, you will bring: • Bachelor's, Master's or PhD in Life Sciences, Biomedical Sciences, Chemistry, Engineering or a related discipline. • Significant Regulatory Affairs experience within the IVD / diagnostics industry. • Strong knowledge of FDA regulations and EU IVDR. • Proven experience developing and executing regulatory strategies for diagnostic products. • Demonstrable experience leading or contributing significantly to FDA submissions and successful product clearances/approvals. • Experience preparing and maintaining EU IVDR technical documentation and working with Notified Bodies. • Direct experience communicating and negotiating with regulatory authorities. • Strong understanding of the complete IVD product lifecycle, from development and clinical validation through commercialization and post-market activities. • Experience working cross-functionally with R&D, Clinical, Quality and Commercial stakeholders. • Ability to manage multiple complex regulatory programs and priorities simultaneously. • Strong communication and leadership skills with the ability to influence stakeholders at both technical and executive level.

Experience within molecular diagnostics, immunoassays, clinical chemistry, companion diagnostics or other complex IVD technologies would be particularly valuable.