Quality & Regulatory Engineer

Join Ansana – Revolutionizing Surgical Instrument Reprocessing

Quality & Regulatory Affairs Engineer

Ansana isn’t just a startup. Our mission is to take on one of the biggest challenges in healthcare: infection control. We’re 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), you’ll ensure that our medical devices meet the highest regulatory and quality standards throughout their lifecycle. You will be a key player in shaping and maintaining Ansana’s 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 you’ll 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 3–4 years of relevant experience.
• Bachelor’s degree in Engineering or a related field required; a Master’s degree is preferred.
• Experience in Quality 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 augusta.poteliunaite@nlc.health