We are seeking an experienced Regulatory Affairs professional to lead IVD (in vitro diagnostic devices) regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for performance evaluation studies and marketing authorizations, and serve as the key regulatory representative for our global project teams. The role can be home or office based in various European locations. Key Responsibilities: * Develop comprehensive regulatory strategies for performance evaluation studies. * Support the preparation of technical documentation of IVDs products. * Represent the regulatory affairs function in integral project teams and governance meetings. * Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings. * Manage regulatory activities throughout the IVD clinical development lifecycle and marketing authorization. * Maintain global regulatory databases with accurate and current information.
* Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions. * Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function. Skills And Experience: * University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline. * Minimum 5+ years of experience in regulatory affairs for IVD. * In-depth knowledge of EU IVDR, ISO 13485 and ISO 20916. * Knowledge of EU MDR regulation, international regulatory framework and experience in medical devices would be a plus. * Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., performance evaluation studies, CE certifications). * Strong track record representing companies during regulatory audits and inspections. * Excellent communication and interpersonal skills. * Fluent in English, written and spoken. * Proficiency with re