Senior QARA Officer

Senior QARA Officer

The company is a rapidly expanding global company specialising in AI-assisted medical image analysis. Since its inception in 2014, they've evolved from a science-driven start up to a leading force in AI-powered pulmonary analysis. Collaborating with pharmaceutical and medical technology firms, we drive advancements in drug development and treatment while integrating precision medicine innovations into clinical practice.

The AI software, through integration partners, is utilised by medical experts worldwide, enriching health care delivery. With a team representing 15 nationalities and diverse backgrounds, we foster a naturally inclusive environment valuing both talent and personality. In this role:

• Join the Quality Assurance and Regulatory Affairs Team, contributing to the mission by ensuring quality and regulatory compliance in medical device development and related health services.
• Lead and support continuous improvement initiatives such as change control, CAPA management, and document control.
• Provide quality assurance guidance to R&D teams across software development phases.
• Maintain the QMS documents in compliance with standards/regulations and assist in QMS process implementation.
• Facilitate risk management activities in alignment with ISO 14971.

Job Requirements:

• Higher professional education.
• Minimum of 5 years of relevant QA/RA experience in the medical device industry.
• Proficiency in managing quality management systems compliant with ISO 13485 and IEC 62304.
• Expertise in guiding medical device software teams according to IEC 62304.
• Experience in securing CE certification for medical devices per (EU) 2017/745 Medical Device Regulations.
• Experience in obtaining FDA clearance per US - Part 820 of Title 21 of CFR - Quality System Regulation (QSR).
• Strong understanding of risk management in compliance with ISO 14971.
• Excellent verbal and written English communication skills (C1 level).

Practical Information:

• Boasting approximately 50 employees from diverse international backgrounds.
• Office location: Nijmegen.
• 32-40 hours per week with hybrid work options available.
• Part-time arrangements can be considered.
• EU passport or valid work permit in the EU required.
• 25 vacation days based on a 40-hour contract, plus 8% holiday allowance.
• 8% pension allowance with a flexible pension plan.

Why Choose Us?

• Competitive salary and ample opportunities for personal development.
• Proudly making a positive impact on people's lives.
• Vibrant and supportive team culture.
• Balancing hard work with enjoyable experiences.
• A commitment to mutual growth and success.