Regulatory & Quality Compliance Lead

Panda International; Amsterdam; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading medical equipment firm is seeking a Quality Assurance Associate in Amsterdam. The role involves managing product registrations, maintaining quality management systems, and ensuring compliance with regulations. Ideal candidates will have a strong background in quality assurance and experience in the medical device industry. Full-time position with a focus on collaboration across teams.

Qualifications

• Experience in managing global product registrations.
• Knowledge of ISO 13485 and EU MDR regulations.
• Background in quality assurance within the medical device industry.

Responsibilities

• Own global product registrations and support marketing teams.
• Maintain ISO 13485-certified QMS across production network.
• Manage CE marking processes for medical devices.

Skills

Regulatory compliance

Quality Management Systems (QMS)

CE marking processes

Post-market surveillance

Collaboration with regulatory partners

Job description

Overview

Direct message the job poster from Panda International

Responsibilities

• Own global product registrations and support marketing teams with regulatory documentation
• Maintain and improve ISO 13485-certified QMS across outsourced production network
• Manage CE marking processes for Class I & II medical devices
• Ensure compliance with EU MDR, FDA, and other market-specific regulations
• Serve as point of contact for notified bodies, competent authorities, and regulatory partners
• Oversee technical file development and post-market surveillance activities
• Coordinate with contract manufacturers (CMOs) to uphold product quality standards
• Sign off quality documentation and drive continuous improvement initiatives
• Act as the bridge between commercial, R&D, and external QA/RA agencies
• Promote a quality-first mindset across the organization while working at scale-up speed

Seniority and Employment

• Seniority level: Associate
• Employment type: Full-time

Job Function and Industries

• Job function: Quality Assurance and Project Management
• Industries: Medical Equipment Manufacturing and Retail Pharmacies