Quality Assurance And Regulatory Affairs Manager (Remote)

Quality Assurance And Regulatory Affairs Manager | Amygdal | Italy

Our client, a Milan-based pioneering MedTech startup specializing in the development of percutaneous solution in the structural heart field , class III medical device, currently in the preclinical stage, is looking for a,

Quality Assurance and Regulatory Affairs Manager

Key Responsibilities,

• Quality Assurance. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable international regulations. Lead the quality activities related to medical device development: design control, change control, risk management, vendor qualification and others.
• Regulatory Affairs. Develop regulatory strategies to optimize product development to achieve CE marking (MDR) and FDA (PMA) approval. Implement the strategy and oversee the preparation and submission of regulatory documents (FDA pre-sub/Q-sub, IDE, ethical committees, competent authorities, and others). Support the internal team providing regulatory feedback and guidance throughout product development cycle.
• Management. Manage a small team, collaborate with R&D and Clinical Affairs departments and external partners and consultants.
• Compliance. Ensure compliance with MDR, FDA, and other relevant regulations, while overseeing internal and external audits
• Documentation. Responsible for Document Control. Manage and maintain technical documentation for Class III medical devices (Investigator’s Brochure, Design History File, Technical Files)
• Liaison with Regulatory Authorities. Engage with global regulatory bodies to facilitate market approval processes acting as company representative developing and maintaining positive relationships with reviewers throughout oral and written communications.

Requirements:

• Master’s degree
• 7+ years of experience in the medical device industry, with experience in Class III devices
• Experience in cardiovascular field is considered a plus
• Experience with new devices development
• Deep knowledge of MDR and FDA regulatory frameworks

· Experience in managing and maintaining Design History Files

· Experience in drafting Technical Files and/or 510k or PMA submissions

· Knowledge of ISO 13485 and other applicable standards is considered a plus

· Experience with FDA is a strong advantage

· Prior startup experience is a plus

· Strong leadership skills with experience managing small teams

· Fluent English (oral and written)

Location: Milan

Full time with remote working flexibility, but in-office presence required on a weekly basis

Contratto di lavoro: Tempo pieno

Retribuzione: €60.000,00 – €85.000,00 all’anno

Domande di preselezione:

• Hai esperienza nel ruolo con class III medical devices?

Lingua:

• Inglese (Obbligatorio)

Tagged as: remote, remote job, virtual, Virtual Job, virtual position, Work at Home, work from home