QA / RA Manager – Make an impact, great flexibility

Location:

Utrecht, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

132431725

Posted On:

10 November 2025

QA/RA Manager (Medical Devices) – Hybrid / Remote (Netherlands)

About the company
A fast-growing and innovative medical device scale-up in the Netherlands developing bioresorbable, minimally invasive solutions for treating voiding dysfunctions. The company combines scientific expertise in soft-tissue augmentation and polymer technology with a mission to improve patient quality of life through safer, more effective treatments.

About the role
As QA/RA Manager, you’ll take full ownership of the Quality & Regulatory system and play a key role in guiding the organisation through its MDR transition. This role is ideal for someone who thrives in an environment with a lot of freedom, flexibility, and autonomy. The culture is not hour-focused but results-driven, offering opportunities for broad professional development and exposure to multiple areas of the business.

You’ll act as the company’s reference point for Quality and Regulatory Affairs, working closely with leadership and occasionally presenting to the board. The position includes extensive audit involvement, interaction with CMOs and suppliers, and a real opportunity to make visible impact within a small, collaborative organisation.

Key responsibilities

Lead and maintain the QMS in accordance with ISO 13485:2016 and oversee the MDD x2192; MDR 2017/745 transition.
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Manage audits, CAPAs, and supplier quality activities, ensuring alignment with compliance standards.
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Oversee technical documentation, vigilance, PMS/PMCF, and product registrations.
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Collaborate cross-functionally with R&D, Operations, and external partners to maintain quality throughout the product lifecycle.
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Represent QA/RA in board and strategic discussions, supporting continuous improvement and risk management.

Qualifications

Strong experience in Quality Assurance / Regulatory Affairs within medical devices (Class II/III).
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In-depth knowledge of MDR 2017/745, MDD 93/42/EEC, and ISO 13485.
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Experience with audits, supplier/CMO management, and MDR documentation.
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Independent, structured, and collaborative mindset with strong communication skills.
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Bachelor’s or Master’s in a relevant field (Quality, Biomedical, or Engineering).

What’s offered

90% remote work – only 1 day per month on-site.
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High degree of flexibility and autonomy, results-driven culture.
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Exposure to board-level discussions and strategic decision-making.
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Significant learning and growth opportunities across QA/RA and operations.
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Occasional travel to international conferences.

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