Team Lead Regulatory Affairs (m/f/d)

STRATEC develops and produces fully automatic analysis systems for leading partners in in vitro diagnostics and life science. From concept to finished product - we make everything in-house and count on the comprehensive know-how of our employees.

Looking for a new challenge with social added value?

Then become part of our team in Birkenfeld

DISCLOSURE: You monitor and evaluate national and international regulatory requirements (IVDR, FDA, standards) and take action Ensure compliance with regulatory requirements and environmental requirements (RoHS, REACH, WEEE) In the optimization and harmonisation of global RA processes within the group of companies, You are contact person for regulatory issues in project teams (F&E, QM, production) You support communication with authorities and designated bodies as well as the Post Market Surveillance and Vigilance Themes You accompany the implementation of internal and external audits in the regulatory context

You have a 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 well-founded experience in professional and disciplinary leadership of teams You have profound knowledge of relevant regulations (e.g. IVDR, ISO standards, 21 CFR 8xx) and international environmental policies You have experience in collaborating in interdisciplinary project teams and supporting internal and external audits You have very good English skills in word and writing You work safely with modern office software and draw your attention through an analytical, solution-oriented approach You bring the willingness to travel