Kempers Recruiting & Consulting GmbH | Germany | 21xxx, 49xxx, 38xxx, 37xxx, 29xxx, 28xxx, 27xxx, 26xxx Niedersachsen | Permanent position | Full time | Published since: 04.05.2026 on stepstone.de
Senior Manager Regulatory Affairs
MANDANT DESCRIPTION Our client has been one of the world's leading manufacturers of laboratory equipment and production facilities for biotechnology, pharmacy and medicine for decades. The products used worldwide in research, clinical applications and production are characterized by the highest quality and innovative developments. Our customer always stands for the highest satisfaction of customers worldwide. The company develops and manufactures products according to the highest quality requirements for the best customer benefit. The group of companies is based in Lower Saxony and is regarded as the world's leading innovation provider; the commitment to research and development is a great commitment. This position is strengthened by technological innovations in freeze drying and laboratory centrifuges. Dozens of patents of the company and the employees are an unmistakable proof of this.
For our clients, we are looking at a location in Lower Saxony: Senior Account Manager (m/w/d) As Senior Regulatory Affairs Manager, you are responsible for the global approval and compliance of centrifuges and freeze-drying equipment of our client. In this role, you control complex, international licensing projects and work closely with authorities, designated bodies and partners in different countries. They design regulatory strategies for different markets and ensure that global standards and requirements as well as GMP requirements are consistently implemented. In addition, you advise development and management in market-relevant decisions and accompany the entire product life cycle. The position offers high responsibility, international visibility and significant influence on the global market presence of the group of companies. .
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Your tasks • Your profile • What we offer
Reported to: Management / CTO Number of employees: none Your duties Strategic planning and control of all regulatory and normative activities over the entire product lifecycle and ensuring compliance Support in the creation, maintenance and release of technical documentation and responsibility for submission Coordination and implementation of national and international authorisation procedures (e.g. CE, MDR/IVDR, Machine Regulation, EMC, Safety Standards) Implementation of regulatory GMP requirements Consultation of product development (design control) and evaluation of product changes incl. Risk and impact analyses Assessment of international regulatory changes and derivation of measures for existing and new products Building and developing regulatory processes, workflows and standards Systematic market and standards monitoring (regulatory intelligence) and deriving strategic measures Sovereign communication with designated bodies, authorities, testing institutes and external partners Close cooperation with quality management, development, production, service and sales in complex issues Preparation and monitoring of external audits/inspections and internal system and process audits The acceptance of responsibility in Regulatory Affairs requires the compliance of the company that you will shape and develop.
Completed studies (e.g. engineering or natural sciences) Multiannual, detectable experience in Regulatory Affairs — ideally in the environment of technical devices, life science, laboratory or medical technology Detailed knowledge of relevant regulations and standards (e.g. MDR/IVDR — if applicable, machine regulation, ISO 13485/9001, ISO 14971, EMC and safety standards) Routinized in handling complex licensing projects and international markets Embossed analytical skills, high detail accuracy and decision strength Communication strong, enforceable and sovereign in exchange with authorities Very good knowledge of German and English in word and writing
Strategically shaped role with high responsibility and design space Influence on future products and regulatory roadmaps Personal development and technical deepening in the global environment Modern working conditions and attractive conditions
Location
 | Kempers Recruiting & Consulting GmbH | |
| Niedersachsen | ||
| Germany |
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