MECTRON SPA, a leading designer and manufacturer of dental and medical devices, is seeking a Regulatory Affairs Specialist.
The Regulatory Affairs Specialist will assist the Senior Regulatory Affairs Manager in registering medical devices in EXTRACEE countries in accordance with a constantly updated plan aligned with company strategy.
* Prepares, updates, and reviews documents for regulatory dossiers in compliance with EU MDR 745/2017 and international requirements.
* Develops and manages technical documentation needed for submissions and registrations.
* Collaborates with project development teams to collect information for submissions and registrations, providing guidance on regulatory processes and compliance.
The successful candidate will be responsible for:
* Registering, monitoring, and maintaining registrations for medical devices in EXTRACEE countries' competent authorities.
* Assisting in Compliance to Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority, and other regulatory agencies.
* Ensuring proficiency in applicable standards and regulations, including ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines.
* Preparing and updating Quality and Regulatory Agreements for registration purposes, distribution contracts, and technical assistance for EXTRACEE countries.
* Fostering adherence to corporate quality procedures and standards to achieve and maintain adequate results.
* Participating in audit activities.
Required Qualifications:
* At least 3 years of experience in Regulatory Affairs in the medical device industry.
* ISO 13485 certification.
* Fluency in English.
* Internal Auditor Qualifications preferred.
Educational Requirements:
* Bachelor's Degree in a scientific discipline.
* Higher-level education degree preferred.