Quality Assurance & Regulatory Affairs (QARA) Specialist

About the role

As our new Compliance Expert, you are the driving force behind our company’s quality and regulatory compliance. This is a solo role, meaning you will take full ownership of compliance execution while working hands-on and in close collaboration with management, product, tech, and medical specialists. Your mission is to ensure our products, processes, and policies meet the highest standards of quality, security, and regulatory compliance while embedding a culture of excellence across the company—always keeping the success of the business as your north star.

About Us:

Quin is a dynamic organization specializing in healthtech, digitalizing patient inflow processes in 1st and 2nd care, with a strong commitment to quality and regulatory compliance. We currently hold ISO 27001/NEN 7510 certifications, ensuring the highest standards for information security and data protection, and are in the process of obtaining ISO 13485 certification, which will align us with international standards for medical devices.

We are seeking a highly skilled and experienced Quality Assurance & Regulatory Affairs (QARA) Specialist to support and further strengthen our quality management systems (QMS) across these certifications. This role will play a critical part in ensuring compliance with industry regulations and certifications while collaborating with external MDR (Medical Device Regulation) specialists to obtain ISO 13485 certification.

Key Responsibilities:

ISO 27001/NEN 7510 Maintenance & Improvement:

• Ensure ongoing compliance with ISO 27001 and NEN 7510 standards for information security management.
• Conduct internal audits, risk assessments, and reviews of security protocols.
• Collaborate with cross-functional teams to resolve non-conformities and implement corrective and preventive actions (CAPAs).
• Monitor and report on information security management system (ISMS) performance, preparing necessary documentation for internal and external audits.

ISO 13485 Certification Support:

• Actively contribute to the development and implementation of the Quality Management System (QMS) for ISO 13485.
• Establish, maintain, and continuously improve the technical documentation and medical device files in accordance with MDR requirements.
• Lead or support CE marking activities, including classification, conformity assessment, and liaison with notified bodies or competent authorities as needed
• Support in the post-market surveillance (PMS) requirements and ensure compliance with vigilance and incident reporting obligations

Hands-on Execution & Cross-Team Collaboration

• This is a solo role, requiring direct involvement in execution while working closely with management, product, tech, and researchers.
• Conduct internal quality audits and risk management activities with a proactive approach.
• Partner with teams across the company to raise awareness of compliance and risk management.
• Drive awareness campaigns to embed a strong quality-first mindset within the organization.

Engage with Authorities & Handle Compliance Incidents

• Manage registrations and communications with competent authorities and notified bodies.
• Handle non-conformities, customer complaints, and regulatory incidents with a solution-driven mindset

Cross-Functional Collaboration:

• Work closely with the IT, R&D, and production teams to ensure all processes meet regulatory and quality standards.
• Collaborate with external experts and consultants, specifically MDR specialists, to support the certification process and ensure regulatory alignment.

Your Profile:

Qualifications & Experience:

• Strong knowledge of quality management systems and industry standards.
• Hands-on, proactive, and highly collaborative.
• Comfortable working independently in a solo role while engaging closely with multiple teams.
• Fluent in Dutch or English.
• Detail-oriented with a hands-on approach to compliance and the ability to meet deadlines.

Skills & Competencies:

• Strong analytical, problem-solving, and risk management skills.
• Excellent communication skills, with the ability to work effectively across various teams and with external consultant
• Hands on experience with ISO 27001, NEN 7510 and understanding of ISO 13485 would be a plus.

What We Offer:

• Competitive salary and benefits package.
• Opportunity to work in a growing, innovative company in the healthtech industry
• Professional development and training opportunities.
• A dynamic and supportive team environment.

If you have a passion for ensuring the highest quality standards, regulatory compliance, and are ready to make an impact as part of an evolving company, we encourage you to apply.