QA/RA Specialist: Dental/Additive Manufacturing (Freelance)

QA/RA Specialist: Dental/Additive Manufacturing

Location: Eindhoven, Netherlands (Hybrid / Remote)

Engagement: Part-time contract | Start ASAP | 6-12 months

An innovative medical device company in Eindhoven is seeking an experienced Medior to Senior QA/RA professional to support regulatory and quality activities for dental and/or additive manufacturing technologies on a project basis.

This role requires hands-on involvement in FDA 510(k) and EU MDR activities and would suit a QA/RA Specialist, Engineer, or Project Manager with strong regulatory execution experience.

Key Responsibilities

• Lead and support FDA 510(k) submissions and/or EU MDR technical documentation
• Prepare, review, and maintain Technical Files / Design Dossiers
• Ensure compliance with ISO 13485, 21 CFR Part 820, and applicable MDR requirements
• Support risk management activities in line with ISO 14971
• Interface with internal stakeholders (R&D, Manufacturing, Clinical, Suppliers) on regulatory and quality topics
• Support supplier quality activities, including documentation review and compliance alignment
• Contribute to change control, design changes, and regulatory impact assessments
• Act as QA/RA point of contact during project phases, audits, and regulatory interactions

Required Experience

• Medior to Senior-level QA/RA background within medical devices
• Proven experience filing FDA 510(k) and/or working through EU MDR procedures
• Strong preference for experience in dental devices and/or additive manufacturing
• Solid understanding of medical device QMS and regulatory frameworks
• Able to work independently in a project-driven environment