Regulatory Affairs Manager

We are partnering with a global leader in transfusion and infectious disease diagnostics seeking a Regulatory Affairs Manager to join its Regulatory & Quality team. This is a pivotal role overseeing global product registrations and compliance activities across the product portfolio, ensuring regulatory excellence from development through to post-market.

Key Responsibilities:

Regulatory Leadership

• Lead regulatory strategy and execution for global product registrations, renewals, and submissions (EU IVDR, FDA BLA/510(k)/PMA, Health Canada, and rest-of-world)
• Ensure technical documentation and EU declarations of conformity are maintained and compliant with ISO 13485, IVDR, and FDA regulations
• Interpret evolving legislation and guide senior management and cross-functional teams on compliance strategy

Operational Oversight

• Oversee preparation, review, and submission of regulatory dossiers supporting new product approvals and post-market activities
• Manage assessments of product changes and coordinate notifications to regulatory agencies
• Serve as the company’s regulatory contact for competent authorities, business partners, and distributors

Team Management & Cross-Functional Collaboration

• Lead, mentor, and develop the Regulatory Affairs team, fostering accountability and technical excellence
• Collaborate with Quality, R&D, and Manufacturing to ensure alignment of regulatory objectives and operational delivery
• Contribute to the design and implementation of quality systems that support continuous improvement and compliance

Ideal Candidate

• Degree or advanced qualification in life sciences or regulatory affairs
• Extensive experience leading regulatory submissions (BLA, 510(k), PMA, CE-IVDR/IVDD) within diagnostics or medical devices
• Deep understanding of regulatory frameworks including ISO 13485, FDA CFR, and international medical device regulations
• Proven leadership experience managing regulatory teams and complex projects
• Skilled communicator with strong influencing and stakeholder management capabilities
• Fluent in English; additional languages beneficial

If you’re a strategic regulatory leader who thrives in a global, science-driven environment, and want to shape the compliance foundation for innovative diagnostics, this is an opportunity to make a lasting impact.