Regulatory Affairs Specialist Uri

Regulatory Affairs Specialist
Uri
Sardegna, Uri

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

Regulatory Affairs SpecialistThe 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

Responsibilitiesprepares, 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 complianceRegisters, 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 RequirementsBachelor's Degree in scientific discipline;

Higher-level education degree preferred.