Job
Regulatory Affairs Manager (m/f/d)
Tuttlingen
Experienced Professionals
Full-time
Permanent
Hettich isn't just a globally operating company with over 120 years of tradition, but also a place where innovation, collaboration, and dedication go hand in hand. As a manufacturer of high-performance laboratory centrifuges and incubators, Hettich sets standards in this field and enjoys worldwide recognition.
Our success is built on our approximately 500 highly qualified and goal-oriented employees, who form the backbone of our company. We take pride in providing an inspiring work environment that fosters creativity and personal growth while continuously striving to exceed the needs of our customers.
Your tasks
- Creation, maintenance, and further development of technical documentation in accordance with the MDR and IVDR
- Ensuring the conformity and approval of our products for placing on the market (focus: MDR Class IIa and IVDR Class A)
- Collaboration in the development and implementation of regulatory strategies for new and existing products
- Planning and execution of international approvals (focus: EU and Asia)
- Communication with Notified Bodies and regulatory authorities, as well as support during audits and reviews
- Management and further development of post-market surveillance and vigilance processes, including the evaluation of incidents
- Responsibility for the risk management process in accordance with ISO 14971
- Assessing the regulatory implications of changes within the change control framework
- Coordinating external partners in the areas of clinical and performance evaluation (CER, PER)
- Serving as the acting PRRC
Your profile
- Bachelor’s or master’s degree in a scientific, technical, or regulatory field
- Several years of professional experience in the field of regulatory affairs for medical devices
- In-depth knowledge of the MDR and the requirements for technical documentation
- Experience in preparing and evaluating PER / PEP / CER / CEP / PMS documentation
- Experience in dealing with Notified Bodies and regulatory authorities
- Good knowledge of relevant standards (especially ISO 13485, ISO 14971)
- Experience with change control processes is a plus
- Very good command of German and English
- Structured, independent, and solution-oriented approach to work
What we offer
Secure job in medical technology industry
Uncover more than just job stability and embrace the chance to actively contribute to the advancement of medical technology.
Individual training and further education opportunities
During annual employee reviews, we define customized development goals that align with your needs and career objectives.
Flexible working hours: Empowering your work-life balance
At Hettich, we value work-life balance, providing flexibility with measures like adjustable hours and extra leave for success in both your professional and personal life.
Company and sports events
Special annual events such as our Advent barbecue, jubilee celebrations, and participation in sports activities bring our employees together and strengthen the sense of community.
Hansefit
With HANSEFIT, our team stays fit and healthy! Through membership, our employees gain access to a wide network of gyms and sports facilities, promoting well-being and strengthening team spirit.
Interested?
Then simply apply directly through our application form.
At our company, employees value the close collaboration and respectful teamwork within our teams.
We're seeking dedicated team members who share our values and want to shape the future together with us.
How can I assist you?
If you're passionate about innovation, teamwork, and making a difference, we'd love to hear from you.
Stefanie Schulz
HR
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