Regulatory Affairs Specialist

Mectron Medical; Carasco; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in dental and medical devices is seeking a Regulatory Affairs Specialist to support compliance with EU MDR and various international regulations. The role involves preparing regulatory documentation and collaborating with project teams. Ideal candidates will have significant experience in Regulatory Affairs, alongside relevant qualifications and certifications.

Competenze

• 3+ years' experience in Regulatory Affairs in medical devices.
• Fluent in English.
• Internal Auditor qualifications preferred.

Mansioni

• Prepare and review regulatory documents according to EU MDR and international standards.
• Manage technical documentation for submissions and registrations.
• Ensure compliance with relevant medical device regulations.

Conoscenze

Regulatory compliance

Documentation preparation

ISO standards knowledge

Audit participation

Project interaction

Formazione

Bachelor's Degree in a scientific discipline

Higher-level education degree preferred

ISO 13485 certification

Descrizione del lavoro

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

1. Prepares, updates, and reviews documents for regulatory dossiers in accordance with EU MDR 745/2017 and international requirements.
2. Prepares and manages technical documentation needed for submissions and registrations.
3. Interacts with project development teams to gather information for submissions and advise on regulatory compliance.
4. Registers, monitors, and maintains registrations for the company's medical devices with EXTRA-CEE countries' authorities.
5. Assists in ensuring compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Regulations, FDA, TGA, ANVISA, Japan Authority, and other agencies.
6. Proficient in standards and regulations such as ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines.
7. Prepares and updates Quality and Regulatory Agreements for registration, distribution, and technical assistance in EXTRA-CEE countries.
8. Follows and promotes corporate quality procedures and standards to achieve and maintain compliance.
9. Participates actively in audit activities.

Work Experience - Required Qualifications

• At least 3 years of experience in Regulatory Affairs within the medical device industry preferred.
• ISO 13485 certification.
• Fluent in English.
• Internal Auditor qualifications preferred.

Educational Requirements

• Bachelor's Degree in a scientific discipline.
• Higher-level education degree preferred.