Quality & Regulatory Engineer at Ansana (medtech startup) – Revolutionizing Surgical Instrument Reprocessing

Maastricht - Netherlands

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Quality & Regulatory Affairs Engineer

Location: Maastricht Netherlands
Full-time

Ansana isnt just a startup. Our mission is to take on one of the biggest challenges in healthcare: infection control. Were engineering next-generation sterilization technology to make the reprocessing of medical devices dramatically faster safer and more sustainable.

If you want to work at the intersection of innovation quality and regulation - ensuring groundbreaking technology meets the highest standards - this is your opportunity to make a real impact.

Your Role

As a Quality & Regulatory Affairs Engineer (QARA) youll ensure that our medical devices meet the highest regulatory and quality standards throughout their lifecycle. You will be akey player in shaping and maintaining Ansanas Quality Management System (QMS) supporting product certifications and driving compliance across our organization.

You will report to the COO and collaborate closely with R&D Manufacturing and Clinical teams as well as external partners and suppliers. This is a hands-on role where youll balance structure and agility - combining analytical rigor with a problem-solving mindset.

Key Responsibilities

Develop implement and maintain the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.
Support regulatory submissions and product registrations (including 510(k) CE marking and other international certifications).
Conduct risk assessments and lead activities such as hazard analysis FMEA and fault tree analysis.
Perform internal and external audits to assess compliance and readiness for regulatory inspections.
Collaborate with R&D to embed quality and regulatory requirements into the design and development process.
Support validation plans and ensure proper documentation for hardware software and system components.
Monitor complaints and field data ensuring effective CAPA processes and continuous improvement.
Serve as the main quality and regulatory contact for customers suppliers and external auditors.

Who You Are

Experience & Education

This is a junior role ideal for recent graduates or candidates with up to 34 years of relevant experience.
Bachelors degree in Engineering or a related field required ; a Masters degree is preferred.
Experience inQuality Assurance or Regulatory Affairs within the medical device or healthtech industry is an advantage.

Technical Skills

Knowledge of ISO 13485 FDA regulations and risk management tools (e.g. FMEA).
Familiarity with validation protocols statistical techniques or data analysis methods is a plus.

Languages

English: Business fluent (required)
Dutch: Business fluent (preferred)

Core Competencies

Analytical Mindset: Able to assess complex systems and identify root causes with precision.
Organizational Skills: Structured and detail-oriented managing timelines and documentation effectively.
Agility: Open to challenging the status quo and adapting to a fast-moving environment.
Customer Focus: Dedicated to building trust and ensuring satisfaction among internal and external stakeholders.
Collaboration: Works effectively across functions and with external partners.
Ownership: Takes initiative drives results and follows through on commitments.

What We Offer

Autonomy & Ownership: Operate with real independence take the lead on projects and shape processes that make a difference.
High Impact: Your work directly influences product compliance safety and readiness for market every action counts.
Access to Leadership: Work closely with senior executives gaining mentorship and visibility rarely found in larger organizations.
Tight-Knit Team: Join a small dynamic team of four where collaboration is direct and your contributions matter.
Startup-competitive remuneration.

For more information please contact

Quality & Regulatory Affairs EngineerLocation: Maastricht NetherlandsFull-timeAnsana isnt just a startup. Our mission is to take on one of the biggest challenges in healthcare: infection control. Were engineering next-generation sterilization technology to make the reprocessing of medical devices dr...