Regulatory Affairs Specialist for Medical Devices

Job description

We are currently seeking a highly skilled and dedicated individual to join our team in a critical role, as Regulatory Affairs Specialist for Medical Devices, based in our offices in Greece- Attika, Marousi.

As a Regulatory Affairs Specialist, the main responsibility of this role is to establish and maintain the regulatory compliance of GMT products in a sustainable way and to support our long-term relationship with customers.

You will be part of a dynamic and challenging team, aiming for continuous improvement and development.

Responsibilities:

• Prepare and file regulatory documentation for premarket submissions and technical files to secure product regulatory approvals for EU and non-EU markets.


• Review and approve IFUs, labeling, promotional materials, and artworks for compliance with regulations


• Maintain and update the in-house regulatory approvals database.


• Provide regulatory support during audits.


• Stay updated with local, EU (MDR), and FDA guidelines, regulations, and best practices related to medical devices.


• Ensure compliance with the company’s Quality Management System (QMS) and quality policies

Education:

• Bachelor’s degree in natural or health sciences.


• Proficiency in English; additional foreign language skills are a plus.

Experience & Skills:

• At least 1 year of proven experience in Regulatory Affairs for Medical Devices, Pharmaceuticals, or PPE.


• Strong analytical and problem-solving skills.


• Excellent written and verbal communication skills in Greek and English.


• Advanced computer skills, including proficiency in Microsoft Office and regulatory databases.

How much will you earn?

Salary is subjected to candidate. Our aim is for all GMT team members to evolve and grow together with the company, and everyone is rewarded for contributing to our mutual development. If you want to learn more, if you think you are the right fit for us and we are the right fit for you, feel free to contact us!