GRA Device Associate

About This Role

This role will contribute to global regulatory strategies for in-vitro diagnostic technologies and support the global regulatory affairs device team within Sanofi's R&D department. The associate will bridge technical development and regulatory compliance, optimizing product approval pathways.

Responsibilities

• Partner with the Device Regulatory Lead on assigned projects
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Contribute to and execute innovative and sustainable medical device regulatory strategies covering IVDs elements
• Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify IVD regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Prepare and review design control deliverables
• Contribute to product development and lifecycle management planning, providing regulatory impact assessments for proposed product changes

Requirements

• 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience
• 3+ years of relevant IVD regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
• Experience responding to Health Authority questions
• Experience preparing regulatory documentation and familiarity with standard submission processes
• Understanding of clinical development of medicinal products, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets
• Working knowledge with technical/industry standards related to global IVD regulations (US FDA IDE/PMA, EU IVDR), technical documentation, ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies
• Bachelor's degree in a scientific or engineering discipline
• Fluency in English

Qualifications

• Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.
• 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3+ years of relevant IVD regulatory experience with contributions to regulatory filings and implementation of regulatory strategies

Nice to Have

• Graduate degree

Skills

* Required skills

Benefits