Mectron SPA, a leading manufacturer of dental and medical devices, is seeking an experienced Regulatory Compliance Manager
The ideal candidate will assist the Senior Regulatory Affairs Manager in registering medical devices in EXTRA-CEE countries, ensuring compliance with EU MDR 745/2017 and international regulations.
Key Responsibilities:
* Prepare, update, and review regulatory documents for submission and registration;
* Collaborate with project development teams to collect information for submissions and registrations;
* Register, monitor, and maintain registrations for medical devices in EXTRA-CEE countries;
* Ensure compliance with Medical Device Regulations (MDR) in the EU, Canada, FDA, TGA, ANVISA, Japan, and other regulatory agencies;
* Familiarity with applicable standards and regulations, including ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines;
* Prepare and update Quality and Regulatory Agreements for registration purposes and distribution contracts;
* Follow and promote corporate quality procedures and standards;
* Participate in audit activities.
Requirements:
* At least 3 years of experience in Regulatory Affairs in the medical device industry;
* ISO 13485 certification;
* Fluency in English;
* Internal Auditor Qualifications preferred;
* Bachelor's Degree in a scientific discipline;
* Higher-level education degree preferred.