Regulatory Affairs Specialist

MECTRON SPA, A DESIGNER AND MANUFACTURER OF DENTAL AND MEDICAL DEVICES IS LOOKING FOR

Regulatory Affairs Specialist

The Regulatory Affairs Specialist assists the Senior Regulatory Affairs Manager in the registration of medical devices in EXTRA-CEE countries following a plan that is constantly updated in accordance with company strategy.

Essential Duties and Responsibilities

• prepares, updates and reviews the documents for use in regulatory dossiers in accordance with EU MDR 745 / 2017 and international requirements.
• Prepares and manages technical documentations needed for submission and registrations.
• Interacts with project development teams in order to collect the information needed for submissions / registrations and advise them on matters that are related to regulatory processes and compliance.
• Registers, monitors, and maintains registrations for the company's medical devices with EXTRA-CEE countries' competent authorities as appropriate.
• Assist in the Compliance to the Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority and other regulatory agencies.
• Is also proficient in applicable standards and regulations including :
• ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607 and MEDDEV guidelines.
• Prepares and updates the Quality and Regulatory Agreements necessary for registration purposes, distribution contracts and technical assistance for the EXTRA-CEE countries concerned.
• Follows and promotes corporate quality procedures and standards in order to achieve and maintain adequate results.
• Actively participate in audit activities.

Work Experience - Required Qualifications

• At least 3 years' experience with Regulatory Affairs in the medical device industry preferred.
• ISO 13485.
• Fluent in English.
• Internal Auditor Qualifications preferred.

Educational Requirements

• Bachelor's Degree in scientific discipline.
• Higher-level education degree preferred.