Regulatory Affairs Specialist (Medical Devices)

Salary: €4,500–€5,700 gross per month for a full-time position, depending on knowledge and experience.

Company

hirify.global is a European healthcare company providing medical products, services and solutions, with Medeco focused on medical devices and own-brand products.

What you will do

• Prepare, review and maintain technical documentation and technical files for medical devices.
• Support conformity assessment and certification for cosmetic devices and Class I, IIa and IIb medical devices.
• Ensure continued compliance with the European Medical Device Regulation (EU MDR 2017/745).
• Monitor legislation, regulations and standards and translate changes into practical actions.
• Support the Quality Management System in accordance with ISO 13485 and contribute to audits and continuous improvement.
• Coordinate post-market activities, supplier and manufacturer requirements, inspections, audits and regulatory follow-up.

Requirements

• Bachelor’s or master’s degree in Biomedical Sciences, Pharmacy, Life Sciences, Chemistry, Biomedical Engineering or a related field.
• Approximately 2 or more years of experience in Regulatory Affairs, Quality Assurance or medical devices.
• Knowledge of EU MDR 2017/745, ISO 13485 and Quality Management Systems.
• Experience with technical documentation, conformity assessment, product certification and medical-device lifecycle management.
• Analytical, structured working style with the ability to manage several regulatory topics simultaneously.
• Good communication skills and good command of English; Dutch is an advantage.

Nice to have

• Knowledge of post-market surveillance, vigilance and complaint handling.
• Experience with toxicological or biological safety assessments.
• Dutch language skills.

Culture & Benefits

• Work in an international healthcare organisation connected to product quality, patient safety and sustainable healthcare.
• Develop Regulatory Affairs expertise across a broad and evolving medical-device portfolio.
• Collaborate with Quality, Regulatory, Sourcing, Product Management and other specialists across hirify.global.
• Contribute to healthcare products and services used by patients and healthcare professionals across Europe.
• Professional environment supporting initiative, continuous improvement and personal development.