Job Title

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 LeadershipLead 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 regulationsInterpret evolving legislation and guide senior management and cross-functional teams on compliance strategyOperational OversightOversee preparation, review, and submission of regulatory dossiers supporting new product approvals and post-market activitiesManage assessments of product changes and coordinate notifications to regulatory agenciesServe as the company’s regulatory contact for competent authorities, business partners, and distributorsTeam Management & Cross-Functional CollaborationLead, mentor, and develop the Regulatory Affairs team, fostering accountability and technical excellenceCollaborate with Quality, R&D, and Manufacturing to ensure alignment of regulatory objectives and operational deliveryContribute to the design and implementation of quality systems that support continuous improvement and complianceIdeal CandidateDegree or advanced qualification in life sciences or regulatory affairsExtensive experience leading regulatory submissions (BLA, 510(k), PMA, CE-IVDR/IVDD) within diagnostics or medical devicesDeep understanding of regulatory frameworks including ISO 13485, FDA CFR, and international medical device regulationsProven leadership experience managing regulatory teams and complex projectsSkilled communicator with strong influencing and stakeholder management capabilitiesFluent in English; additional languages beneficialIf 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.