Quality and Regulatory Affairs Manager

📋 Description

• Prepare and oversee regulatory and quality documentation for CE mark applications and reviews by Notified Bodies.

• Collaborate with technical, clinical, and various teams, providing training and guidance with assistance from external CE consultants.

• Aid in the development and management of the Quality Management System (QMS).

• Assist in the preparation and maintenance of the Technical File, which includes gathering information, compiling evidence, drafting documentation, and working closely with engineering, design, and data teams.

• Support ISO certification activities (e.g., ISO 13485).

• Ensure document control, maintain records, logs, and change control to guarantee audit readiness and ongoing compliance.

• Serve as the primary contact for consultants and the Notified Body, crafting responses and scheduling audits.

• Coordinate requirements, risk assessments, usability, and verification evidence with product, design, and engineering teams.

• Contribute to post-market surveillance activities following approval.

• Monitor timelines, prepare status updates, and promote collaboration across teams.

⛳️ Requirements

• 3 to 6 years of experience in quality assurance, regulatory, or product documentation roles.

• Strong sense of ownership, organizational skills, and proficiency in document management.

• Technical aptitude and comfort in collaborating with engineering or product teams.

• A degree in engineering or a related technical discipline.

• Experience in digital health, Software as a Medical Device (SaMD), or a similar regulated technology environment.

• Knowledge of ISO certification processes.

🏝️ Benefits

• 25 days of annual leave.

• Access to a 24/7 Employee Assistance Program (EAP) and a variety of health and well-being supports.

• A comprehensive list of employee perks and benefits.