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 SeniorRegulatory Affairs Managerin 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, updatesand reviews the documents for use in in regulatory dossiers in accordance with EU MOR 745/2017 and international requirements.
• Prepares and manages technicaldocumentations needed for submission and registrations;
• Interacts with project developments 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 theCompliance 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 achieveand 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.