Regulatory Affairs Consultant: Medical Device IVDR
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In 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.
Responsabilità- Develop 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
- University 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 13485 and ISO 20916
- 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 13485
- ISO 20916
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Pavia (PV), Provincia di Pavia; Lombardia, Italia PAREXEL Tempo pienoOverview In 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...
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