Regulatory Affairs Consultant – Medical Device, Combination Product Expert

This is a fully remote position, open to applicants in Italy.

📋 Description

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

• Act as the regulatory affairs representative in global project teams and governance meetings.

• Lead regulatory communications with health authorities and notified bodies, including the preparation of documentation and arranging meetings.

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

• Maintain up-to-date global regulatory databases with accurate information.

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

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

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

• Contribute to initiatives for continuous improvement, innovation, and strategic planning within the regulatory function.

⛳️ Requirements

• A university degree in a scientific field, with a technical or life science degree required, preferably in biopharmaceutical or bioscience-related disciplines.

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

• Extensive knowledge of global medical device regulations, especially EU MDR.

• Familiarity with US FDA regulations is an advantage.

• Demonstrated experience in global regulatory strategy and the preparation of technical documentation for the EU (e.g., clinical investigations, Notified Body opinions, CE certifications).

• Understanding of the medical devices regulatory framework, including EU-MDR, ISO 13485, and ISO 14155.

• Experience with in vitro diagnostic devices would be beneficial.

• Proven history of representing companies during regulatory audits and inspections.

• Excellent communication and interpersonal skills.

• Proficiency in English, both written and spoken.

• Familiarity with regulatory systems such as Veeva and TrackWise is a plus.

🏝️ Benefits

• Health insurance

• Professional development opportunities