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Head of Quality Management & Regulatory Affairs

Head of Quality Management & Regulatory Affairs

Adaptive Business GroupHessen, Germany
Vor 2 Tagen
Stellenbeschreibung

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

    J-18808-Ljbffr