Regulatory Affairs Manager - Lecco, Italia - Digitec srl

Digitec srl

Azienda verificata

Lecco, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

We are looking for a
Regulatory Affairs Manager who will be responsible for formulating and implementing regulatory affairs policies and procedures for our proprietary software medical devices.

As Regulatory Affairs Manager you will be reporting directly to R&D Director and leading another member of staff within the dedicated team.

Key responsibilities and tasks:

Define and direct regulatory strategy inlcuding those activities necessary to obtain Product Certifications
Ensure that all regulatory activities for standalone software are carried out at EU level (Registration and maintenance of EUDAMED and UDI management) and at FDA level (QMS adaptation to FDA requirements, database maintenance and UDI management) in accordance with regulations
Ensure that all regulatory activities are carried out at a Global level
Oversee technical documentation and its submission
Manage relations with Notified Bodies and Competent Authorities
Keep constantly up to date with technical standards, laws and regulations
Provide compliance training in terms of medical devices design, verification and validation
Ensure postmarket surveillance (reporting, incidents etc both on domestic and international database)
Ensure internal company procedures and regulatory working instructions are up to date
Keep documentary evidence produced by departments you collaborate with
Ensure accuracy of sw documentation (requirements, management and architecture, testing etc.)
Collaborate in sw release and verify relevant evidence is ready when releasing
Participate in cross function meetings to evalute products new features, ensuring feasibility standards are met

Requirements: