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Regulatory Affairs Specialist - Medical Devices

The Regulatory Affairs Specialist manages all processes such as distribution agreement implementation, product registrations, post market surveillance and customer requests in order to ensure regulatory compliance of our medical devices on the market and customer satisfaction.

• Great Growth Opportunity|Experience as Regulatory Affairs in medical devices market is required

• Implement and maintain distribution agreements with key partners to ensure regulatory compliance on the market.
• Support the distribution of the medical devices to be in compliance with the local requirements obtaining authorizations, licences and registrations required for distributing the medical devices in the involved markets and their periodic update/renewal.
• Keep the relevant departments updated on the device registrations status and the authorized markets.
• Support to maintain an up-to-date Post-Market Surveillance system and regular update of PMS related processes to ensure regulatory compliance, integrating EU MDR and MDSAP requirements.
• Coordinate cross-functional activities required for PMS (and Vigilance) with other teams and ensure the collection, evaluation and preparation of data for PMS, gathering inputs from cross functional stakeholders.
• Coordinate the complaints management.
• Coordinate the quality and regulatory business support requests to meet the customers' expectation in terms of quality and timing collecting the necessary information from the team or other departments.
• Provide support in the update of the quality management system and internal/external audit preparation.

Biomedical company leader in medical devices production

• A Bachelor's degree in Engineering.
• 1-3 years' experience in global regulatory registrations, post market surveillance and customer communications
• Good time management skills, able to work effectively in a demanding environment

• Perform multiple tasks concurrently with accuracy.
• Well-developed analytical skills and ability to pay particular attention to details.
• Teamworking and positive attitude.
• Advanced written and spoken English and Italian.
• Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, etc)