MECTRON SPA, a renowned designer and manufacturer of dental and medical devices, seeks a highly skilled Regulatory Affairs Specialist.
This role is critical in ensuring compliance with regulatory requirements for medical devices in EXTRA-CEE countries.
Key Responsibilities:
* Prepare, update, and review documents for regulatory dossiers in accordance with EU MDR 745/2017 and international standards.
* Manage technical documentations needed for submissions and registrations, collaborating with project development teams to ensure seamless information collection and regulatory process guidance.
* Register, monitor, and maintain registrations for the company's medical devices with competent authorities in EXTRA-CEE countries.
* Ensure compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority, and other relevant agencies.
* Stay up-to-date on 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 necessary for registration purposes, distribution contracts, and technical assistance for EXTRA-CEE countries.
* Promote corporate quality procedures and standards to achieve and maintain adequate results.
* Participate actively in audit activities.
Required Qualifications:
* At least 3 years' experience in Regulatory Affairs within the medical device industry.
* Proficiency in ISO 13485.
* Fluent English language skills.
* Internal Auditor Qualifications preferred.
Educational Requirements:
Bachelor's Degree in a scientific discipline; higher-level education degree preferred.