The selected candidate will join a team responsible for ensuring compliance with applicable requirements for our medical devices and cosmetic products, in accordance with Regulation (EU) 2017/745 (MDR), EN ISO 13485, and other applicable regulatory requirements in the markets where the company operates.
Main Responsibilities:
• Activities related to the maintenance and continuous improvement of the Company Quality Management System (QMS) in compliance with EN ISO 13485.
• Collaboration in the preparation, review, and update of Technical Documentation for medical devices and Product Information Files (PIFs) for cosmetic products.
• Ensuring ongoing compliance with the requirements of Regulation (EU) 2017/745 (MDR).
• Preparation and management of documentation for audits, certification activities, and regulatory assessments.
• Providing regulatory support for the entry into new international markets.
• Preparation, review, and approval of product labelling, Instructions for Use (IFU), and packaging materials, in collaboration with clients, translators, and designers where applicable.
Candidate Profile:
• Degree in Life Sciences, Pharmacy, Biotechnology, Quality Management, or related disciplines.
• 2–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device and cosmetic sector.
• Solid knowledge of MDR 2017/745, EN ISO 13485, and cosmetic regulation (Regulation (EC) No 1223/2009).
• Strong command of English (written and spoken).
• Highly organized, team-oriented, detail-oriented, proactive, solution-driven, and capable of working autonomously.
• Advanced user of Microsoft Office Suite, particularly Word and Excel.
