GRA Device Associate

Role Summary

GRA Device Associate in the GRA Device Digital and Diagnostic team contributes to global regulatory strategies for in-vitro diagnostic technologies, collaborates with cross-functional teams to navigate complex regulatory landscapes, optimizes product development, and directly influences the success of product approvals through strategic negotiations with health authorities worldwide. The role supports a wide range of diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents, and companion and complimentary diagnostics. You will propose device strategies, conduct risk assessments, and interact with regulatory authorities while preparing high-quality regulatory submissions and ensuring ongoing 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 thoughtful risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submissions timelines; ensure appropriate 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 a regional/local regulatory lead and point of contact with Health Authorities for projects/products in remit
• Support operational and compliance activities for assigned deliverables; develop and execute regulatory submission planning activities
• Contribute to internal regulatory processes and procedures for IVD

Qualifications

• Experience: 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3+ years of relevant IVD regulatory experience; contributions to regulatory filings and implementation of regulatory strategies; experience 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 (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of global IVD regulations (US FDA IDE/PMA, EU IVDR), technical documentation, ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies; ability to synthesize and critically analyze data from multiple sources
• Collaboration Skills: Ability to work effectively in a matrix environment; cross-functional engagement with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing and negotiation skills
• Soft Skills: Strategic thinking, initiative, change-agent leadership, and risk assessment proficiency; ability to translate business objectives into actionable project strategies
• Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills, fluent in English
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site); openness to learning and growth

Skills

• Regulatory strategy development
• Regulatory submissions and health authority interactions
• Health authority negotiations and communications
• Risk assessment and mitigation for IVD/medical device regulatory pathways
• Cross-functional collaboration and stakeholder management
• Design controls and regulatory documentation
• Regulatory intelligence and trend analysis

Education

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

Additional Requirements

• Hybrid work environment with 60% on-site presence