Regulatory Affairs Specialist Medical Devices

Job Title: Regulatory Affairs Specialist (Medical Devices)

Location:In-person at Corsano Health in The Hague (minimum 4 days/week in The Hague)

About Corsano Health: Corsano Health is at the forefront of developing, producing, and selling medically certified wearables for continuous vital sign monitoring. Our flagship product, the Corsano Solution, is a CE MDR certified and FDA Cleared system designed to monitor a.o. pulse rate, blood pressure, respiratory rate, SpO2, temperature and activity. We are committed to innovation and excellence in the medtech sector, and we are looking for a talented Regulatory Affairs Specialist to join our dynamic team.

We are seeking a hands-on Regulatory Affairs Specialist to support our day-to-day regulatory and quality assurance activities. You will work closely with our development, testing, and documentation teams to ensure compliance with applicable standards and regulations for medical device software and wearables. This position is involved in processing health information.

Key Responsibilities:

• Post-Market Surveillance (PMS) activities: Collect, analyze, and report PMS data in accordance with MDR and ISO 13485.

• Controlled documentation: Maintain and update controlled documents (SOPs, technical files, design history files, etc.).

• Risk management: Help maintain risk files and ensure alignment with ISO 14971 processes.

• Developer support: Assist software developers in documenting design inputs, outputs, risk analyses, and verification activities per IEC 62304.

• Software testing: Support verification and validation (V&V) documentation, traceability, and test reporting.

• Regulatory support: Prepare documentation for audits, Notified Body submissions, and FDA/CE updates as needed.

Qualifications:

• Bachelor's degree in Engineering, in the field of life sciences / technical or medical devices; preferably knowledge of electronic devices (hardware, software and firmware).

• Proven experience in Regulatory Affairs in the medical device sector (Class II or higher).

• Regulatory experience under ISO 13485, ISO 14971, and the EU Medical Device Regulation (MDR) is a must.

• Regulatory experience with medical device systems (hardware, firmware, apps, cloud) under IEC 62304 is a strong advantage.

• Familiarity with FDA 21 CFR Part 820 requirements.

• Detail-oriented, self-driven, and organized.

• Hands-on experience in a startup or scale-up environment is highly desirable.

• Excellent communication and collaboration skills.

• Fluency in English (written & spoken).

Benefits:

• Competitive Compensation: Attractive salary and performance-based incentives, aligned with company growth and leadership progression.

• Professional Development: Access to leadership training, industry conferences, and a network of seasoned mentors to support your growth.

• Innovative Work Environment: Join a cutting-edge, mission-driven company that fosters collaboration, creativity, and continuous improvement.

This is an exciting opportunity to join a fast-growing MedTech company at a pivotal moment of expansion. As Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and maintaining the highest quality standards for innovative healthcare solutions. Your expertise will drive regulatory strategies, shape the Quality Management System, and help bring life-changing technologies to market. This role offers the chance to make a meaningful impact while advancing your career in a dynamic, mission-driven environment.

Corsano Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.