Head of Regulatory Affairs and Quality Assurance (RA/QA)

Head of Regulatory Affairs and Quality Assurance (RA/QA)

The Head of QA/RA will be responsible for overseeing and managing all quality assurance and regulatory affairs activities within the company. This role will ensure that all products meet the highest standards of quality and comply with applicable regulatory requirements. The ideal candidate will develop and execute strategic plans to ensure continuous improvement and regulatory compliance.

Key Responsibilities:

Regulatory Affairs:

• Lead communication with regulatory authorities, including the FDA and Notified Bodies.
• Oversee CE marking processes and ensure compliance with applicable regulations and standards.
• Lead preparations for Pre-Submissions and 510(k) Submissions to the FDA.
• Manage product CE certification audits by Notified Bodies.
• Lead global expansion and manage worldwide registrations.

Quality Assurance:

• Establish, maintain, and continuously improve the company’s QMS to ensure compliance with applicable regulations and standards.
• Report on the performance of the QMS to senior management, identifying opportunities for improvement.
• Manage the entire lifecycle of QA activities, including supplier quality, product release, non-conformities, customer complaints, corrective and preventive actions, design control documents, engineering change orders, and document control.
• Manage quality system audits by Notified Bodies.
• Ensure compliance with FDA’s QSR, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

Leadership and Mentorship:

• Mentor, train, and provide oversight on RA and QA-related matters to the team.
• Ensure continuous professional development within the QA/RA team.

Experience and Qualifications:

• Degree in biotechnology / medical engineering, or another relevant scientific discipline.
• At least ten years of professional experience in regulatory affairs and in quality management systems related to medical devices.
• Demonstrated experience in managing QMS and leading QA activities.
• Proven track record of successful regulatory submissions and interactions with regulatory authorities.
• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Experience in In-Vitro Diagnostic (IVD) products and Software as Medical Device (SaMD) – an advantage.

Skills:

• In-depth knowledge of applicable regulations and standards (FDA’s QSR, ISO 13485, MDR/IVDR).
• Strong analytical and problem-solving skills.
• Ability to work effectively in a fast-paced and dynamic environment.
• Proficiency in managing multiple projects and priorities simultaneously.
• Ability to manage partners, distributors and consultants globally.