QA/RA Manager

QA/RA Manager - Unity Partners - Vacatures

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.

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

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

Independent, proactive, and able to provide clear guidance in ambiguous situations

On-site presence in Eindhoven is essential (fully remote not possible)

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.

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