Requirements: English
Company: Mectron Medical
Region: Carasco , Liguria
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.