Regulatory Affairs Specialist

Do you want to use your Regulatory Affairs expertise in an international healthcare environment where product quality and patient safety come first? As a Regulatory Affairs Specialist at Medeco, part of Mediq, you play an important role in ensuring that our medical devices meet the highest quality and regulatory standards.

Medeco B.V. is part of Mediq, a leading European healthcare company providing medical products, services and solutions to patients and healthcare professionals. Within Mediq, Medeco plays an important role in the development, manufacturing and regulatory compliance of medical devices and own-brand products.

What are you going to do?

As Regulatory Affairs Specialist, you will be part of our Quality & Regulatory team. You will work on a broad portfolio of medical devices and ensure that products and their technical documentation remain compliant throughout their lifecycle. Your work combines regulatory expertise with collaboration. You will interact with colleagues across Medeco and Mediq as well as suppliers, manufacturers, Notified Bodies and other external partners. You will monitor regulatory developments, translate them into practical actions and help ensure that our products continue to meet applicable European requirements.

Your main responsibilities include:

• Preparing, reviewing and maintaining technical documentation and technical files for medical devices in accordance with applicable European legislation and standards.
• Supporting conformity assessment and certification activities for cosmetic devices and medical devices, including Class I, Class IIa and IIb products.
• Ensuring continued compliance with the European Medical Device Regulation (MDR).
• Monitoring changes in relevant legislation, regulations and standards and assessing their impact on Medeco, Mediq and the product portfolio.
• Supporting and continuously improving the Quality Management System in accordance with ISO 13485 and other applicable requirements.
• Working with internal stakeholders on regulatory and quality requirements during the complete product lifecycle.
• Supporting post-market activities, including vigilance, complaints, monitoring and regulatory follow-up.
• Providing Regulatory Affairs and Quality expertise to colleagues and other stakeholders.
• Working with suppliers and manufacturers to ensure products and processes meet applicable quality and regulatory requirements.
• Identifying when supplier audits, product inspections or First Article Inspections are required based on performance, risk and regulatory requirements.
• Maintaining effective relationships with internal and external stakeholders, suppliers and regulatory partners.
• Contributing to audits, certifications and continuous improvement projects within Quality & Regulatory Affairs.

What is your background?

You are a regulatory professional who enjoys combining specialist knowledge with a practical approach. You understand that regulatory compliance is not just about documentation: ultimately, it is about ensuring that healthcare professionals and patients can rely on safe, effective and high-quality medical products. You are comfortable working in an international environment and enjoy collaborating with colleagues from different disciplines. You are able to interpret complex regulations and translate them into clear requirements and actions for the organisation.

We are looking for:

• A bachelor's or master's degree, preferably in Biomedical Sciences, Pharmacy, Life Sciences, Chemistry, Biomedical Engineering or a related field.
• Approximately 2 or more years of relevant experience within Regulatory Affairs, Quality Assurance or medical devices.
• Knowledge of the European Medical Device Regulation (EU MDR 2017/745).
• Knowledge of ISO 13485 and Quality Management Systems.
• Experience with, or a strong interest in, preparing and maintaining technical documentation for medical devices.
• Understanding of conformity assessment, product certification and medical-device lifecycle management.
• Knowledge of post-market surveillance, vigilance and complaint handling is an advantage.
• Experience with toxicological or biological safety assessments is a strong advantage.
• An analytical and structured way of working and the ability to manage several regulatory topics simultaneously.
• Good communication skills and the ability to work effectively with both technical and non-technical stakeholders.
• Good command of English. Dutch is an advantage.

What does Mediq offer?

At Mediq, you work in an international healthcare organisation where your expertise has a direct connection to the quality, safety and affordability of healthcare. You will have the opportunity to develop your Regulatory Affairs expertise across a broad medical-device portfolio and work with colleagues and partners throughout Europe.

We offer:

• A challenging Regulatory Affairs position within an international healthcare environment.
• The opportunity to work with a broad and evolving portfolio of medical devices and own-brand products.
• Plenty of room to develop your expertise in areas such as MDR, technical documentation, Quality Management Systems, product compliance and post-market activities.
• Collaboration with Quality, Regulatory, Sourcing, Product Management and other specialists across the Mediq organisation.
• A professional environment where initiative, continuous improvement and personal development are encouraged.
• The opportunity to contribute to Mediq's ambition to enable sustainable healthcare across Europe.

About Medeco and Mediq

Medeco B.V. is part of Mediq and focuses on medical devices and products used by healthcare professionals across Europe. Quality, regulatory compliance and patient safety are fundamental to everything we do.

Mediq is a leading European healthcare company supporting patients, healthcare professionals, hospitals and healthcare institutions with medical products, services and solutions.

Would you like to use your Regulatory Affairs expertise to contribute to safe, high-quality medical devices and help shape the future of healthcare? We would be happy to meet you.