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.