Regulatory Affairs Consultant – Medical Device IVDR

This is a fully remote position, open to applicants in Italy, +4 more countries.

📋 Description

• Formulate comprehensive regulatory strategies for performance evaluation studies.

• Assist in the preparation of IVD technical documentation.

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

• Lead interactions with health authorities and notified bodies regarding regulatory matters.

• Prepare regulatory documentation and organize meetings with health authorities and notified bodies.

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

• Maintain global regulatory databases, ensuring all information is accurate and up-to-date.

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

• Contribute to the ongoing enhancement, innovation, and strategic planning within the regulatory function.

⛳️ Requirements

• A university degree in a scientific, technical, or life science field is essential.

• At least 5+ years of experience in regulatory affairs specifically for IVD.

• Thorough understanding of EU IVDR, ISO 13485, and ISO 20916 standards.

• Familiarity with EU MDR, international regulatory frameworks, and medical devices is advantageous.

• Experience in developing global regulatory strategies and preparing technical documentation for EU performance evaluation studies and CE certifications.

• Demonstrated experience representing organizations during regulatory audits and inspections.

• Strong communication and interpersonal skills are required.

• Proficiency in English, both written and spoken, is necessary.

• Experience with Veeva and TrackWise is a plus.

🏝️ Benefits

• Options for home or office-based work.

• Full-time employment.