Job
Head of Regulatory & Quality Affairs (m/f/d)
Tuttlingen
Experienced Professionals
Full-time
Permanent
Hettich isn't just an owner-operated, 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
- Implementing, monitoring and ensuring compliance with regulatory requirements (MDR, IVDR), quality management requirements (esp. EN ISO 13485, EN ISO 9001, EN ISO 14001) and quality assurance requirements
- Creation, management and monitoring of documents for worldwide approvals, registrations and tenders, as well as improving and maintaining the document management system
- Worldwide execution and monitoring of product registrations and approvals as well as classification of medical devices
- Monitoring of the QM, QA, occupational health and safety and environmental protection/management systems
- Preparation, execution and support of audits by e.g. authorities, notified bodies, suppliers, customers etc.
- In the function of Person Responsible for Regulatory Compliance, performance of duties in accordance with the applicable regulations (after appropriate training)
- Leading employees
Your profile
- Completed studies in the field of medicine, pharmacy, engineering, law or other relevant scientific fields
- Several years of professional experience in the field of Regulatory & Quality Affairs
- Extensive experience as a Safety Officer (§30 MPG) or as a Person Responsible for Regulatory Compliance (Art. 15 MDR)
- Profound knowledge of MDSAP company certification
- Experience in managing employees
- Strong communication skills, confident appearance and assertiveness
- Accurate and forward thinking work style
- Very good knowledge of English
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 pension plan
With a company pension plan, we help you to actively provide for your retirement and build up long-term financial security.
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.
Mobile work
Depending on your position, we offer up to 40% flexible mobile working options, whether from home or on the go.
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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