Director, Regulatory Affairs (f/m/d)

Kurz zusammengefasst

ClarioClinical is seeking a Director, Regulatory Affairs to lead their regulatory strategy for medical devices. The role involves overseeing the preparation of submissions, interacting with regulatory bodies like the European Medicines Agency and national authorities, and ensuring compliance throughout the product lifecycle. The main responsibilities include managing the regulatory strategy, preparing submissions, and ensuring compliance. The role also involves mentoring a cross-functional team and driving timely approvals. The ideal candidate must have at least 8 years of regulatory experience in the EU medical-device sector, expertise in MDR/IVDR submissions, and strong leadership skills. A university degree in life sciences, engineering, or a related field is required, along with fluency in English. Proficiency in German is a plus. What the role asks for: - 8 years of regulatory experience in the EU medical-device sector - Expertise in MDR/IVDR submissions - University degree in life sciences, engineering, or a related field - Fluency in English - Strong leadership skills - Proficiency in German (nice-to-have)