As a consultant, you will be embedded in a high-tech innovation environment, supporting Quality Assurance and Regulatory Affairs activities for regulated medical products across international markets. You will contribute to the operational maintenance and continuous improvement of quality systems, with a focus on CAPA management, SOP development, post-market surveillance and regulatory submissions. Working closely with cross-functional stakeholders and international manufacturing teams, including suppliers, you will help ensure regulatory compliance across the EU, US, EMEA and other relevant markets.
Responsibilities
Maintain and improve Quality Management System (QMS) processes, ensuring alignment with applicable international regulatory requirements.
Manage and follow up on CAPA activities, including root cause investigations, corrective actions and preventive measures.
Review, update and develop Standard Operating Procedures (SOPs) and related quality documentation.
Support Post-Market Surveillance (PMS) activities, ensuring appropriate monitoring, documentation and follow-up.
Contribute to Regulatory Affairs activities, including the preparation and coordination of regulatory submissions across international markets.
Support compliance activities related to data privacy and applicable regulatory requirements across the EU, US and EMEA.
Collaborate with international manufacturing and supplier teams, particularly in China, to address quality and compliance topics.
Coordinate with internal stakeholders to ensure timely execution of operational Quality and Regulatory activities.
Skills & Experience
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 relevant regulatory requirements.
Familiarity with international regulatory frameworks, particularly 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 the motivation to learn, take ownership and work with international stakeholders.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this reason, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
