GRA Device Associate

Role Summary

Location: Cambridge, MA; Morristown, NJ; Washington, DC. As a GRA Device Associate in the Device Digital and Diagnostic team, you will contribute to global regulatory strategies for in-vitro diagnostic technologies and collaborate with cross-functional teams to navigate complex regulatory landscapes. You will prepare regulatory submissions, support health authority interactions, and help bring device and IVD products used with or alongside drugs to patients worldwide.

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
• Identifies IVD regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submissions timelines; ensures 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 generating submission content plans, submission tracking, communication and document management
• 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 with 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 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. Ability to synthesize and critically analyze data from multiple sources.
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills
• Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
• Communication: Strong written and verbal communication and influencing skills, with fluency in English.
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

Education

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