My client is searching for a Regulatory Affairs Manager (m/f/d) for in vitro diagnostic medical devices (IVD) who will focus on providing regulatory support for IVDs and companion diagnostics (CDx) throughout the entire product lifecycle and will work on a wide range of tasks. This position offers hybrid working options and is open to 80–100% working hours.

Tasks:

• Ensuring compliance with EU requirements (IVDD 98/79/EC, IVDR 2017/746)
• Development and implementation of tailored solutions to meet regulatory requirements for a wide range of clients, such as diagnostics manufacturers, pharmaceutical companies, or laboratories
• Preparation of technical documentation for a wide range of products, technologies, and indications
• Interactive collaboration with internal experts on all topics related to CE marking of IVDs (preclinical experts, clinicians, QM experts, etc.)
• Implementation of quality management systems, e.g. according to EN ISO 13485:2016 or MDSAP
• Close collaboration with international clients as well as notified bodies and competent authorities
• Development of creative solutions to meet customer needs in conjunction with regulatory requirements

Requirements:

• Completed vocational training or a degree in the natural sciences, medical technology, engineering, or a comparable educational background
• 2+ years of experience in IVD Regulatory Affairs within the IVD industry or at a Notified Body / Authority
• CE marking of IVD products (preferably both reagents and devices)
• Very good command of German and English

Are you interested? Then please send your CV with your contact details to [email protected] or call me on +49 (0) 69 5899 75467

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We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.