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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.