TEAM LEAD REGULATORY AFFAIRS (M/F/D) (Regulatory Affairs Manager)

YOUR TASKS:

• You monitor and evaluate national as well as international regulatory requirements (IVDR, FDA, standards) and derive measures
• You ensure the compliance of products with regulatory specifications and environmental protection requirements (RoHS, REACH, WEEE)
• You participate in the optimization and harmonization of global RA processes within the corporate group
• You are the contact person for regulatory issues in project teams (R&D, QM, Production)
• You support communication with authorities and notified bodies as well as with Post Market Surveillance and vigilance topics
• You accompany the implementation of internal and external audits in the regulatory context

YOUR PROFILE:

• You have a completed degree in natural sciences, pharmacy, medical technology, or a comparable qualification
• You have several years of professional experience in Regulatory Affairs in the medical technology or IVD industry and sound experience in technical and disciplinary leadership of teams
• You possess sound knowledge of relevant regulations (e.g., IVDR, ISO standards, 21 CFR 8xx) and international environmental directives
• You have experience working in interdisciplinary project teams and in accompanying internal and external audits
• You have very good written and spoken English skills
• You work confidently with modern Office software and are characterized by an analytical, solution-oriented way of working

Additional information: Requirements for the applicant: Advanced knowledge: Legal knowledge (medical devices), customer consulting, customer support, Regulatory Affairs (medical technology), information and communication management