QA/RA Manager

Unity Partners exclusively on behalf of our MedTech partner

We have been retained by a fast-growing medical technology scale-up in their search for a hands-on QA/RA Manager. This company develops an innovative medical device combining hardware and software, serving healthcare professionals globally with real-time patient monitoring solutions. ISO 13485 and MDR certified, they are scaling up commercially and expanding into international markets, including the US.

As QA/RA Manager, you will own both the quality and regulatory function, acting as a strategic and operational lead across all compliance topics. This is a role with real weight: you will navigate a complex regulatory landscape, keep the organisation audit-ready, and ensure products meet the highest safety and compliance standards, all within a fast-moving scale-up environment.

This is a role based in Eindhoven, ideal for professionals seeking ownership, autonomy, and direct impact in an ambitious MedTech company.

As QA/RA Manager, you will:

• Own and continuously improve the QMS (ISO 13485), ensuring alignment with MDR and FDA requirements
• Take the lead on regulatory affairs: maintaining and evolving the regulatory strategy for EU (MDR) and US (FDA) markets, including CE and 510(k) documentation
• Prepare and maintain technical documentation, risk assessments, and post-market surveillance (PMS and PMCF) processes
• Prepare for and lead internal and external audits, manage CAPAs, and drive quality improvements
• Serve as the key regulatory point of contact for the management team, notified body, and certified suppliers
• Support R&D and Operations on quality engineering topics throughout the product lifecycle
• Train and inform the broader team on quality and regulatory requirements
• Liaise with leadership on compliance risks, reporting, and continuous improvement

Your Profile:

• Bachelor's or Master's degree in Biomedical Sciences, Medical Technology, Pharmacy, or a related field
• 5+ years of experience in both QA and RA within the medical device industry
• Strong knowledge of MDR, ISO 13485, and FDA CFR Title 21
• Experience with CE marking and 510(k) submissions is a strong plus
• Comfortable preparing technical documentation and coordinating audits end-to-end
• Affinity with SaMD and hardware/software combination devices is an advantage
• Experience with ISO 27001 is a plus
• Independent, proactive, and able to provide clear guidance in ambiguous situations
• Fluent in English; Dutch is a plus
• On-site presence in Eindhoven is essential (fully remote not possible)

Why join?

• Be part of a MedTech company making real impact in patient monitoring and care
• Play a central role in shaping the QA and RA function across EU and US markets
• Join a diverse and informal team with short lines, speed, and ambition
• Competitive salary based on experience, plus stock appreciation rights
• 25 holidays with option to purchase additional days, good pension scheme, and training opportunities

Interested?Let's connect. Unity Partners is exclusively supporting this  search.

‍christian@unitypartners.nl | +31 (0)20 8938 606

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