Global QA & Regulatory Affairs Consultant - Medical Devices

Amaris Consulting; Rotterdam; On-site; EUR 65,000 - 90,000; Full time

Job summary

Amaris Consulting is seeking a Quality Assurance and Regulatory Affairs consultant to support high-tech medical products across international markets. You will contribute to QMS maintenance, CAPA management, SOP development, PMS and regulatory submissions.

Collaborate with cross-functional teams and suppliers, including international manufacturing groups, to ensure regulatory compliance in the EU, US, EMEA and other markets.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Quality Management, Regulatory Affairs or a related field.
• Initial hands-on experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Basic knowledge of Quality Management Systems (QMS), CAPA management and root cause analysis.
• Experience reviewing, maintaining or developing SOPs and other controlled quality documentation.
• Understanding of Post-Market Surveillance (PMS) processes and regulatory requirements.
• Familiarity with EU MDR, FDA requirements and other applicable EMEA regulations.
• Basic understanding of regulatory submissions and market-specific documentation requirements.
• Awareness of data privacy requirements and their application within regulated environments.
• Structured and organised approach to documentation, process management and quality-related activities.
• Strong communication and collaboration skills, with motivation to learn and work with international stakeholders.

Responsibilities

• Maintain and improve QMS processes, ensuring alignment with international regulatory requirements.
• Manage and follow up on CAPA activities, including root cause investigations and corrective actions.
• Review, update and develop SOPs and related quality documentation.
• Support Post-Market Surveillance (PMS) activities with monitoring and follow-up.
• Contribute to Regulatory Affairs activities, including preparation and coordination of regulatory submissions across international markets.
• Support compliance activities related to data privacy and regulatory requirements across EU, US and EMEA.
• Collaborate with international manufacturing and supplier teams to address quality and compliance topics.
• Coordinate with internal stakeholders to ensure timely execution of operational Quality and Regulatory activities.

Skills

QMS knowledge

CAPA management

Regulatory affairs

Documentation

Cross-functional collaboration

Regulatory submissions

Data privacy awareness

Organized approach

Communication

International stakeholders

Education

Bachelor's or Master's degree in Life Sciences/Biomedical Engineering/QA/Regulatory Affairs

Job description

Amaris Consulting is seeking a Quality Assurance and Regulatory Affairs consultant to support high-tech medical products across international markets. You will contribute to QMS maintenance, CAPA management, SOP development, PMS and regulatory submissions.

Collaborate with cross-functional teams and suppliers, including international manufacturing groups, to ensure regulatory compliance in the EU, US, EMEA and other markets.