Manager Regulatory Affairs (m/f/d)

Our client is an internationally operating industrial company headquartered in Germany and other locations in Europe and the USA. Since its foundation in the 1990s, the company has successfully established itself with a technologically unique product idea worldwide. More than 500 employees develop and produce high-quality products exported to over 70 countries at a total of five locations. The company is one of the leading producers of its industry and has a variety of patents and a high level of technological know-how. Modern production facilities and continuous development ensure the top position in international competition. For the location in the Thuringian Eichsfeld, near Heilbad Heiligenstadt, we are looking for a manager Regulatory Affairs (m/w/d) on behalf of the company for a responsible position. In this newly created position, you work closely with the head QM / QS and the departments at the site and create and maintain the technical documentation in accordance with the applicable regulations and legislation.

Are you interested in further information? We look forward to your application!

HAPEKO is the first address for professionals and managers in Germany. The focus of the activity is the creation of links between specialists and executives with a professional desire for change and suitable companies. HAPEKO (www.hapeko.de) is represented throughout Germany with more than 20 locations.

Creation & maintenance of technical documentation Own responsible creation, maintenance and updating of technical documentation (product files, design history files) according to the respective regulations, laws and standards Creation, maintenance and maintenance of conformity declarations Definition of product markings and instructions for use Compilation and evaluation of test and validation reports (including for basic suitability, primary packaging, production, aging, biocompatibility and purity) Regulatory Compliance & Risk Management Continuous monitoring and timely implementation of regulatory requirements (e.g. EU regulations) for all product groups Implementation of Gap analyses for new revisions and adaptation of harmonised standards and test specifications Takeover of risk management and ongoing updating of risk management records (including complaint catastrophes, root analysis and action definition) Regular verification of conformity within the framework of certificate cycles Assessment of raw materials and packaging materials as regards conformity, safety and suitability Registrations, audits & communication company and product registrations and compliance with related documentation and reporting obligations Senior Account Manager (m/w/d) Planning and implementation of internal training on regulatory issues and standards Interdisciplinary cooperation with adjacent specialist departments in defining and implementing conformity measures

You have a degree in law, economics or the like. You are practical, pragmatic, ''open minded'. Good knowledge of German and English will help you to work with internal and external contacts. You work structured and analytically and keep an overview of complex requirements. Ideally, you have your residence near the site in the Eichsfeld, but alternatively you can also work at other German locations of the company (no home office!).

Safe workplace in a future-proof industry with a long-term perspective Versatile and responsible area of responsibility with structured integration Flat hierarchies, short decision paths and open communication Flexible working hours for a balanced work-life balance Individual training and development opportunities Occupational pensions and attractive additional benefits