ACTEGA GmbH | Germany | 31xxx Lehrte | Permanent position | Full time | Published since: 24.06.2026 on stepstone.de
Regulatory Affairs Manager – Medical Devices (m/f/d)
Functional area: Research and development | Target group: Professional | Type of employment: Unlimited employment | Company: ACTEGA | Location(s): Lehrte, Germany | Number of jobs: 481 ACTEGA develops and produces special coatings, printing inks, adhesives and sealing compounds with a focus on packaging, printing and health applications. The focus is on technically demanding solutions and high safety standards, especially for regulated markets. A global production network enables close cooperation with customers worldwide. ACTEGA is part of the ALTANA Group and employs more than 1,300 people worldwide. Sustainability that works At ACTEGA we are innovative because we believe it is better – and because we combine progress with long-term stability. We are successful because people make the difference with us. Based on our financial strength and shared values, we live a culture in which openness promotes development and initiates different perspectives of innovation. Thus we develop solutions that make products of daily life better and more sustainable and sometimes also change entire markets. Special chemistry is our strength. And we make sure that chemistry is also true between us. Find out! !
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Your tasks • Your profile • What we offer
Implementation and guarantee of compliance according to ISO 13485 and implementation of internal audits Creation, maintenance and submission of approval dossiers and technical documentation according to EU-MDR and US-FDA Development and implementation of regulatory strategies for national and international authorisations Communication with designated bodies and external consultants Monitoring and implementation of regulatory changes Post-Market Surveillance and Lifecycle Management Cooperation with R&E, application and sales as well as designated bodies and external consultants
Complete study of natural sciences, engineering, medical technology or a related subject Relevant professional experience in regulatory affairs in an ISO-certified company, preferably in the field of EU-MDR and ISO 13485 Experience in technical documentation and certification procedures Interest in regulatory issues A structured and responsible way of working, sovereign communication strength and secure stakeholder management complete your profile
Excellent health and social benefits Pension provision Attractive working environment Flexible working time regulation Further education and training, e.g. digital training library
Location
 | ACTEGA GmbH | |
| 31275 Lehrte | ||
| Germany |
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