Head of Department – Quality Management & Regulatory Affairs
About the Role
Head of Department - Quality Management System & Regulatory Affairs
Location: Aachen
We are supporting a client in the MedTech industry, specializing in the development and manufacturing of innovative medical devices, in their search for a Head of Quality Management System & Regulatory Affairs. In this role, you will lead a dynamic team, overseeing quality management and regulatory processes to ensure compliance and drive continuous improvement.
Key Responsibilities:
- Lead an interdisciplinary team of experts, fostering a culture of continuous improvement and quality.
- Manage the company’s Quality Management System (QMS) in compliance with international standards (ISO 13485, EU MDR, FDA), and ensure regulatory approvals for medical devices in global markets.
- Oversee risk management strategies and ensure the successful planning, execution, and follow-up of internal/external audits and inspections.
- Collaborate with cross-functional teams in product development, production, and marketing to ensure smooth product launches.
- Monitor trends in regulatory standards and integrate them into the company's strategic planning.
- Improve operational efficiency through the integration of automated software systems, enhancing transparency and regulatory compliance.
Your Profile:
- Degree in medical technology, engineering, natural sciences, or a related field.
- Several years of experience in quality management and regulatory affairs within the medical device industry.
- Strong knowledge of ISO 13485, EU MDR, and FDA regulations.
- Proven leadership skills with experience managing and developing teams.
- Exceptional organizational, communication, and project management skills.
- Fluency in German and English (both written and spoken) is essential.
This position offers the opportunity to lead a key department within a cutting-edge MedTech company, with a focus on driving innovation while maintaining the highest regulatory standards.
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world and are ready to support your career development with them.
Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:
- Expert advice on your CV and cover letter
- Guidance on salary expectations
- Personalized interview preparation
- Connections to exclusive job opportunities
- Assistance in negotiating the best possible offers
- 50% of the CVs we send to clients are accepted
- Accepted or declined, either way we will provide you with feedback
We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com
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