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)
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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)
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