This is a fully remote position, open to applicants in Italy, +5 more countries.

📋 Description

• Create thorough regulatory strategies and technical documentation for medical devices and combination products.

• Act as a representative for Regulatory Affairs in global project teams and governance meetings.

• Oversee regulatory interactions with health authorities and notified bodies, including preparing documentation and coordinating meetings.

• Manage regulatory activities throughout the clinical development lifecycle of devices and the marketing authorization process.

• Keep global regulatory databases updated with accurate and current information.

• Work in collaboration with CMC and QA departments on device change control processes and global submission requirements.

• Assist with internal and external audits related to medical device quality systems.

• Collaborate with cross-functional teams to ensure timely and compliant regulatory submissions.

• Participate in continuous improvement initiatives, innovation, and strategic planning within the regulatory function.

⛳️ Requirements

• A university degree in a scientific discipline, specifically in technical or life sciences, is required, preferably in biopharmaceuticals or a related bioscience field.

• At least 5+ years of experience in regulatory affairs related to medical devices and drug-device combination products.

• Extensive knowledge of global medical device regulations, with a particular focus on EU MDR.

• Demonstrated experience in developing global regulatory strategy and preparing technical documentation for the EU, including clinical investigations, Notified Body opinions, and CE certifications.

• Familiarity with EU-MDR, ISO 13485, and ISO 14155 standards.

• Proven ability to represent companies during regulatory audits and inspections successfully.

• Proficient in English, both written and spoken.

• Understanding of US FDA regulations, experience with in vitro diagnostic devices, and familiarity with Veeva and TrackWise is an advantage.