Director of Quality & Regulation Affairs

Director of Quality & Regulatory Affairs

Role Overview:

We are looking for a Quality Management Specialist to oversee and enhance quality management processes in compliance with ISO standards and regulatory requirements. This role involves acting as the key liaison between internal quality teams, ensuring audit readiness, and driving continuous improvement in quality management systems.

Key Responsibilities:

• Serve as the central communication interface between quality management teams and related organisational units.
• Develop and maintain a quality management concept, ensuring alignment with regulatory and company-wide standards.
• Monitor and document quality management processes in compliance with applicable regulations.
• Prepare and maintain audit documentation to meet regulatory requirements.
• Plan and support internal and external audits, ensuring compliance with ISO and medical device regulations.
• Assess quality performance and propose improvements to management.
• Assist in documenting company-wide quality processes across various departments.
• Ensure compliance with medical device risk management and reporting obligations.
• Prepare management reports and reviews related to quality performance.

Your Profile:

• Degree in natural sciences, engineering, or a related field.
• Minimum 3 years of experience in quality management, ideally within medical devices or regulated industries.
• Experience with internal and external audits.
• Strong analytical and problem-solving skills.
• Structured working style with the ability to collaborate within teams.
• Ability to work independently while driving innovation and optimisation.
• Strong communication and organisational skills, with a strategic mindset.

What We Offer:

• A key role in quality management within a regulated industry.
• Opportunities to shape and improve quality processes.
• Collaboration with cross-functional teams in a dynamic environment.
• Professional development and growth opportunities.