The brandgroup is a medium-sized, internationally expanding family business. We specialize in the development and manufacture of technical springs and bent wire parts. Our springs make an important contribution to the automotive supply industry, the door industry, the white goods industry, as well as the railroad and aviation industries. For decades, our customers have valued our innovative strength, our know-how and our reliability, which we have recently also demonstrated in the fields of medical technology and actuators.
We are looking for a Regulatory Affairs Manager (m/f/d) at the Anröchte site who would like to actively shape the future of our company in the Medical division in this responsible position:
Take responsibility:
- Development of new and efficient concepts for the creation, maintenance and management of technical documentation for class IIa medical devices
- Responsibility for compliance with approval-relevant documents prior to submission and for updating and maintenance throughout the entire product life cycle
- Responsible for planning, implementation and documentation of clinical and biological assessment processes
- Assumption and management of risk management in accordance with ISO 14971 and advice to the development department
- Independent monitoring, evaluation and implementation of national and international regulatory requirements, laws, guidelines and standards (MDR, FDA 510(k) 21 CFR 820, ISO 13485).
- Process management: defining, managing and establishing the necessary processes, work instructions and forms for the approval area
- Assuming the role of deputy PRRC
- Internal advice and training: Competent answers to colleagues' approval-related questions and advice on new developments; preparation of specification documents.
Skills that convince:
- Completed degree in engineering or natural sciences with at least 3 years of relevant professional experience or comparable training e.g. BTA, CTA, MTA or PTA with appropriate further training and at least 5 years of relevant professional experience
- Further training in regulatory affairs
- Relevant national and international regulations (laws,
- Know and understand regulations, directives, standards) such as Regulation (EU) 2017/745 (MDR), FDA 510(k), ISO 13485, ISO 9001, ISO 14971
- Participation in audits by notified bodies
- High deadline and quality awareness
- Independent work and approach to problem solving
- Sense of responsibility, diligence, ability to work under pressure
We offer:
- a responsible and varied job in a successful company
- Flat hierarchies with short decision-making paths
- a performance-related salary
- Christmas and holiday bonuses
- Berufliche Weiterbildungs- und Entwicklungsmöglichkeiten
- Business bike
Working hours: Full-time
Referenznummer: BRA-ZS-ME-ANR-20251023-43
Your complete application documents Please send your salary expectations and availability to:
Bewerbung@brand-group.com
The brandgroup team looks forward to receiving your application!
