Gerolymatos International S.A. is one of the most reputable and well-esteemed family-owned businesses in the Greek healthcare industry dating back to 1923.
Τhe company operates in Greece, 3 distinct local business divisions addressing OTC Consumer healthcare needs, Vision Care and Animal, while at a global level, holds a network of affiliated companies and local distributors, making its own products accessible to consumers in more than 50 countries worldwide.
Regulatory Affairs Associate
Location: Kryoneri, Greece, 145 68
Gerolymatos International AEBE is currently seeking a Regulatory Affairs Associate, who will be responsible for the Medical Devices files’ update and maintenance, literature and technical documentation analysis, as well as the day-to-day support in regulatory requests by the Department’s Director.
Main responsibilities
- Τranslate, update, and co-approve the packaging materials (Instructions for Use leaflet, outer box, primary packaging information such as label) of products in compliance to the Guidelines/Regulations in force.
- Ensure, within scope, that Company’s (already approved) products with the provisions of the regulatory bodies and the Regulations in force (locally and/or internationally).
- Collaborates with Company’s departments (marketing, Supply Chain, Quality assurance, Medical Affairs) as well as external /third-party partners regarding matters related to company’s products portofolio.
- Undertake additional (ad hoc) duties as per company’s needs
Job Requirements
- University degree in Βiology, Pharmacology, Veterinary Medicine or relevant field
- Master or Phd Degree in the field of science will be an asset.
- At least 5 year experience in a Regulatory Affairs Department of Medical Devices.
- Previous experience with MDR745/2017.
- Excellent command of the English language both written & spoken.
- Excellent knowledge of Microsoft office and ADOBE Acrobat Pro.
- Advanced attention to detail and communication skills will be considered a major asset.
- Clean and clear personality, team spirit, goal motivation.
- Must be a confident and motivated individual with a drive for progress.
What we offer
- Additional Private health insurance
- Group Pension Plan
- Employee assistance program
- Hybrid work model
The company's commitment is to create a working environment that will inspire and reward its people, seeking continuous personal development, based on the principles of dedication and ethics. We are proud to have Diversity and Inclusion at the center of everything we do and are committed to providing equal employment opportunities regardless of race, color, nationality, national identity, gender, age, disability, sexual orientation, or religion.