Head of Quality Management & Regulatory Affairs
Location: Marburg, Germany (Hybrid)
Overview:
This company has been developing and manufacturing innovative in vitro diagnostics and medical devices for over 40 years and selling them globally.
* Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Company Bonus Scheme provided.
* Work with Management: This position allows you to collaborate with senior management, internal departments, and external stakeholders.
* Permanent Full-Time Position: Permanent employment in a leading global company with secure future prospects.
* 30 Days Holiday: and other tailored benefits.
* Responsible and varied tasks: that allow you to have an interesting and varied job across RAQM.
* Team Events: benefit from being part of a wider global operation.
Tasks:
The Head of QM & RA oversees Quality Management and Regulatory Affairs, ensuring compliance, continuous QMS improvement, and effective coordination between management, departments, and stakeholders.
Key Responsibilities:
Leadership & Team Management:
* Oversee the QARA team, including task delegation and absence planning.
* Facilitate communication between management, departments, and team members.
* Ensure smooth collaboration and workflow across projects.
Quality Management:
* Maintain and enhance the QMS (DIN EN ISO 13485).
* Oversee technical documentation and compliance with EU Regulation 2017/746 (IVDR).
* Lead CAPA, root cause analysis, complaint management, and post-market surveillance.
* Act as Management Representative, conducting QMS reviews and reporting to leadership.
* Ensure regulatory compliance and drive process improvements.
Regulatory Affairs:
* Manage all regulatory compliance activities and act as PRRC.
* Oversee product registrations for domestic and international markets.
* Provide necessary certifications and handle recalls/field safety notices.
Safety & Compliance:
* Serve as Deputy Radiation Protection Officer, ensuring radiation safety compliance.
* Advise as a Medical Device Consultant and conduct internal audits.
Your Profile:
* Bachelor or Master’s degree in biotechnology, Biopharmaceutical Technology, or a related field.
* At least 3 years of experience in a role focused on technical documentation, regulatory affairs, or quality management.
* Certified Internal Auditor.
* Completion of PRRC training (2024) or willingness to complete.
* Proficiency in DIN EN ISO 13485 and EU IVDR standards.
* Strong leadership and team management skills.
* Analytical and organizational abilities.
* Fluent in English and German proficiency is a must.
For more information, please contact Luke Fines:
+49 30 1663 4514
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance, Other, and Manufacturing
Industries: Medical Equipment Manufacturing
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