GRA Device Lead (Associate Director) - Digital Health
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
The GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical device and digital health technologies, collaborates with cross-functional teams to navigate regulatory landscapes, optimizes product development and manufacturing processes, and influences product approvals through negotiations with health authorities worldwide. The role supports a wide range of digital health technologies, including digital biomarkers, wearables, SaMD, and connected devices, developing device strategies, conducting risk assessments, and serving as the primary liaison with regulatory authorities. 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 Identify DHTs regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed Lead 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, 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 regional/local regulatory lead and point of contact with Health Authorities for projects/products in remit Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations Contribute to the development of a harmonized regulatory voice through device committees and forums Support operational and compliance activities for assigned deliverables; develop, execute regulatory submission planning activities, including submission content plans and document management Contribute to internal regulatory processes and procedures for DHTs Accountable for regulatory assessment for DHTs Due Diligence activities as applicable May lead a Device GRT as Device Global Regulatory Lead (dGRL), including additional responsibilities such as guiding the Device GRT, aligning team on mission and strategy, advocating regulatory positions, and representing GRA at governance committees Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience; experience contributing to regulatory filings and responding to Health Authority questions Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials to enable digital endpoints and SaMD development; proficiency in preparing regulatory documentation with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability; ability to synthesize and 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; 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, 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 Additional Requirements
Hybrid work environment with 60% on-site work
#J-18808-Ljbffr
The GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical device and digital health technologies, collaborates with cross-functional teams to navigate regulatory landscapes, optimizes product development and manufacturing processes, and influences product approvals through negotiations with health authorities worldwide. The role supports a wide range of digital health technologies, including digital biomarkers, wearables, SaMD, and connected devices, developing device strategies, conducting risk assessments, and serving as the primary liaison with regulatory authorities. 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 Identify DHTs regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed Lead 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, 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 regional/local regulatory lead and point of contact with Health Authorities for projects/products in remit Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations Contribute to the development of a harmonized regulatory voice through device committees and forums Support operational and compliance activities for assigned deliverables; develop, execute regulatory submission planning activities, including submission content plans and document management Contribute to internal regulatory processes and procedures for DHTs Accountable for regulatory assessment for DHTs Due Diligence activities as applicable May lead a Device GRT as Device Global Regulatory Lead (dGRL), including additional responsibilities such as guiding the Device GRT, aligning team on mission and strategy, advocating regulatory positions, and representing GRA at governance committees Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience; experience contributing to regulatory filings and responding to Health Authority questions Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials to enable digital endpoints and SaMD development; proficiency in preparing regulatory documentation with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability; ability to synthesize and 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; 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, 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 Additional Requirements
Hybrid work environment with 60% on-site work
#J-18808-Ljbffr