Head of QA&RA for a Medical Software company

This senior position encompasses regulatory oversight of both AI technologies and information security, ensuring comprehensive compliance across our software solutions in healthcare.

Management of the ISO 13485 standard, CE and FDA compliant Quality Management System. Overall responsible for QMS maintenance and improvements.

Plan and deliver the regulatory registration / submission documentation to the relevant authorities, with special focus on AI/ML regulatory requirements and information security standards.

Responsible for ensuring business activities are conducted in compliance with the regulations and standards applicable to our business and product range, including AI-specific regulations and cybersecurity requirements.

Responsible for managing and maintaining ISO 27001 compliant Information Security Management System and for the implementation of Information Security requirements in the company.

Requirements:

BSc in any field of knowledge

Previous experience in a similar function

Certificate of lead auditor

Knowledge of ISO 13485, FDA CFR 820, IVDR 2017/746, ISO 14971, ISO 27001, and privacy regulations (GDPR, HIPAA)

Experience in QMS management and RA in medical devices

Previous experience and related course ISO 27001

Experience with AI/ML regulatory requirements and cybersecurity standards is required

Excellent communication and presentation skills

Quick learner of new technologies