RA Specialist

Unity Partners on behalf of our MedTech partner

Our partner is an ambitious and fast-growing medical device company developing a high-risk device. With innovation at its core, the company is building next-generation technology designed to improve patient care. As the organization prepares for further clinical and commercial milestones, they are strengthening their QA/RA capabilities to ensure compliant, scalable, and high-impact product development.

As Regulatory Specialist, you’ll be the regulatory backbone of the product development team. You’ll guide cross-functional teams through design controls, risk management, and regulatory documentation, ensuring compliance with international standards (ISO 13485, FDA 21 CFR 820, MDR). This is a critical, hands-on role with high impact—perfect for someone who thrives in a fast-moving, collaborative environment.

Key Responsibilities

·      Represent RA in cross-functional product development teams.

·      Own and improve design control processes: planning, inputs/outputs,verification/validation, and transfer.

·      Write, review, and manage regulatory documentation: DHF, DMR, requirements, test protocols, and more.

·      Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.

·      Participate in design reviews, proactively identifying gaps and risks.

·      Provide expert interpretation of relevant standards, especially in the Class II/III domain.

·      Lead continuous improvement in QMS processes related to design and development.

·      Support CAPA, change control, and risk-based decision-making processes.

Your Profile

·      Bachelor's or Master’s degree in Biomedical, Mechanical, Electrical Engineering or a related field.

·      5+ years of relevant experience within the medical device industry.

·      Expertise in design controls, risk management, and relevant regulatory frameworks.

·      Confident communicator with excellent documentation skills.

·      Hands-on, structured, and excited to work in a scaling, impact-driven environment.

What’s on Offer

You’ll join a dynamic and forward-thinking MedTech company at a pivotal stage of growth. In this role, you’ll play a vital part in bringing an innovative medical device to market, with real influence over quality and compliance in a regulated development environment. Surrounded by a collaborative international team, you can expect competitive terms, a strong technical mandate, and the opportunity to grow into a senior QA/RA leadership role as the company scales.

📩 Want to learn more or apply? Reach out via christian@unitypartners.nl

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