OverviewIn this Regulatory Affairs Lead role, you shape IVD regulatory strategies, guiding performance evaluation and marketing authorizations.
You will act as the regulatory lead for global project teams, coordinating interactions with authorities and ensuring compliant submissions.
The role supports lifecycle management and continuous improvement within Parexel's regulatory function.
It offers hybrid or remote work across multiple European locations and meaningful impact on patient health.
ResponsabilitàDevelop regulatory strategies for performance evaluation studies
Support preparation of technical documentation for IVD products
Represent regulatory affairs in global project teams and governance meetings
Lead regulatory interactions with health authorities and notified bodies, including meeting prep
Manage activities throughout the IVD clinical development lifecycle and marketing authorization
Maintain global regulatory databases with current information
Coordinate with cross-functional teams for timely regulatory submissions




Contribute to continuous improvement, innovation, and strategic planning within regulatory
Requisiti fondamentaliUniversity degree in a scientific discipline; technical or life science degree required
Minimum 5+ years of experience in regulatory affairs for IVD
In-depth knowledge of EU IVDR, ISO ***** and ISO *****
Knowledge of EU MDR and international regulatory framework; experience in medical devices a plus
Proven experience in global regulatory strategy and EU technical documentation (performance evaluation studies, CE certifications)
Strong track record representing companies during regulatory audits and inspections
Excellent communication and interpersonal skills
Fluent in English, written and spoken
Proficiency with regulatory systems including Veeva and TrackWise would be a plus
Excellent communication
Interpersonal skills
Cross-functional collaboration
EU IVDR
ISO *****
ISO *****

📌 Regulatory Affairs Consultant: Medical Device Ivdr - Home Or Office Based In Various Eu Locations (Bardi)
🏢 Parexel
📍 Bardi