GRA Device Lead (Associate Director) - Digital Health
Scorpion Therapeutics, Trenton, New Jersey, United States
Role Summary
GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical device and digital health technologies, collaborating with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through negotiations with health authorities worldwide. Responsibilities
Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products) Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions Identifies DHTs regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Lead 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, review and approve 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 Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums 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 DHTs Accountable for regulatory assessment for DHTs Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes additional responsibilities: fully accountable decision maker for global regulatory strategies; leads the Device GRT; ensures alignment and communication as “one GRA voice”; represents GRA at governance committees Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience and experience in regulatory filings and strategy development Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials and SaMD development; proficiency in regulatory documentation and standard submission processes Technical Knowledge: Understanding of clinical development, device design controls, manufacturing processes, and regulatory requirements in major markets; familiarity with software development lifecycle, labeling, risk management, clinical evaluations, and usability Collaboration Skills: Ability to work in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influence and negotiation skills Soft Skills: Strategic thinking, initiative, change leadership, and risk assessment capabilities 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 environment (60% on-site) Education
Bachelor's degree in a scientific or engineering discipline Graduate degree preferred Additional Requirements
Hybrid work environment (60% on-site)
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GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical device and digital health technologies, collaborating with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through negotiations with health authorities worldwide. Responsibilities
Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products) Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions Identifies DHTs regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Lead 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, review and approve 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 Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums 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 DHTs Accountable for regulatory assessment for DHTs Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes additional responsibilities: fully accountable decision maker for global regulatory strategies; leads the Device GRT; ensures alignment and communication as “one GRA voice”; represents GRA at governance committees Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience and experience in regulatory filings and strategy development Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials and SaMD development; proficiency in regulatory documentation and standard submission processes Technical Knowledge: Understanding of clinical development, device design controls, manufacturing processes, and regulatory requirements in major markets; familiarity with software development lifecycle, labeling, risk management, clinical evaluations, and usability Collaboration Skills: Ability to work in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influence and negotiation skills Soft Skills: Strategic thinking, initiative, change leadership, and risk assessment capabilities 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 environment (60% on-site) Education
Bachelor's degree in a scientific or engineering discipline Graduate degree preferred Additional Requirements
Hybrid work environment (60% on-site)
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