GRA Device Associate

Role Summary

GRA Device Associate in the GRA Device Digital and Diagnostic team contributing to global regulatory strategies for in-vitro diagnostic technologies. You will collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and influence product approvals through strategic negotiations with health authorities worldwide. The role involves supporting a range of diagnostics, proposing device strategies, conducting risk assessments, and preparing regulatory submissions to bring innovative therapies to patients.

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
• Liaises with device, clinical, manufacturing, commercial, and other internal business 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 their remit, as needed
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generation of submission content plans, submission tracking, communication 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 relevant IVD regulatory experience and contributions to regulatory filings; 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
• Collaboration Skills: Ability to work effectively 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 and risk assessment proficiency; ability to translate business objectives into actionable project strategies

Skills

• Strong written and verbal communication; ability to influence; fluency in English
• Ability to synthesize and critically analyze data from multiple sources

Education

• Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.

Additional Requirements

• Adaptability: ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)