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MECTRON SPA, a designer and manufacturer of dental and medical devices, is looking for a 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
* Prepare, update, and review documents for regulatory dossiers in accordance with EU MDR 745/2017 and international requirements.
* Prepare and manage technical documentation needed for submissions and registrations.
* Interact with project development teams to collect information needed for submissions/registrations and advise on regulatory compliance matters.
* Register, monitor, and maintain registrations for the company's medical devices with EXTRA-CEE countries' authorities as appropriate.
* Assist in compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Regulations, FDA, TGA, ANVISA, Japan authorities, and other agencies.
* Proficient in standards and regulations including ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines.
* Prepare and update Quality and Regulatory Agreements for registration, distribution contracts, and technical assistance in the EXTRA-CEE countries.
* Follow and promote corporate quality procedures and standards to achieve and maintain compliance.
* Participate actively in audit activities.
Work Experience - Required Qualifications
- At least 3 years of experience in Regulatory Affairs within the medical device industry preferred.
- Fluent in English.
Educational Requirements
Bachelor's Degree in a scientific discipline.
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