GRA Device Associate

Role Summary

GRA Device Associate responsible for contributing to global regulatory strategies for in-vitro diagnostic technologies, collaborating with cross-functional teams to navigate regulatory landscapes, optimize product development, and influence product approvals through negotiations with health authorities. Supports a range of diagnostics and interacts with regulatory authorities while preparing regulatory submissions and ensuring compliance.

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 IVD 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 risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submissions timelines; ensure communication, resolution and/or escalation as needed
• Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes
• Prepare and review design control deliverables
• Contribute to product development and lifecycle management planning; provide regulatory impact assessments for proposed product changes
• May serve as regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
• Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including content plans, submission tracking, and document management
• Contribute to internal regulatory processes and procedures for IVD

Qualifications

• Experience: 6+ years in pharmaceutical/biotechnology/medical device industry with 3+ years of IVD regulatory experience; experience contributing to regulatory filings and responding to Health Authority questions
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of clinical development of medicinal products, IVD development (design controls), manufacturing processes, and regulatory requirements in major markets; knowledge of global IVD regulations (US FDA IDE/PMA, EU IVDR), ISO standards (13485, 15189), CLIA, LDTs, and clinical performance studies
• Collaboration Skills: Ability to work in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing, and negotiation skills
• Soft Skills: Strategic thinking, initiative, change agent leadership, risk assessment proficiency
• Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
• Communication: Strong written/verbal communication and English fluency
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid environment (60% on-site)

Skills

• Regulatory strategy development
• IVD regulatory submissions
• Health Authority interactions
• Design controls and regulatory impact assessments
• Cross-functional collaboration
• Risk assessment and mitigation
• Regulatory documentation and standard submission processes

Education

• Bachelor's degree in a scientific or engineering discipline; graduate degree preferred