GRA Device Lead (Associate Director) - Digital Health

Role Summary

GRA Device Lead (Associate Director) - Digital Health. Drive global regulatory strategies for medical device and digital health technologies, collaborate with cross-functional teams to navigate complex 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
• Identify DHTs regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submission timelines; ensure 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 development and monitoring of global regulatory environment and updates to device regulations
• Contribute to harmonized regulatory voice through device committees/forums
• Support operational and compliance activities for assigned deliverables; develop and execute regulatory submission planning activities
• Contribute to internal regulatory processes for DHTs
• Accountable for regulatory assessment for DHTs Due Diligence activities

May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT with additional responsibilities:

• The dGRL is the accountable decision maker for development and execution of global regulatory strategies to meet objectives
• Leads the Device GRT, aligning team on mission, prioritization, objectives and expectations for device regulatory strategy including global labeling strategy
• Ensures alignment and communication as “one GRA voice” to advocate regulatory position to governance and committees
• The dGRL is the single GRA point of contact for the DHTs program and represents GRA at device team, global project team, and internal 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 regulatory strategy development
• Regulatory Expertise: Ability to develop device regulatory strategies to support implementing DHTs into clinical trials and SaMD development; proficient in preparing regulatory documentation and standard submission processes
• Technical Knowledge: Understanding of clinical development of medicinal products, device design controls, manufacturing processes, and regulatory requirements in major markets; familiarity with software development lifecycle, design controls, labeling, software documentation, 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 and negotiation skills
• Soft Skills: Strategic thinking, initiative, change leadership and risk assessment; ability to translate business objectives into actionable strategies
• Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills; English fluency
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid environment (60% on-site)

Skills

• Regulatory strategy development for DHTs, SaMD, and digital biomarkers
• Health authority interactions and regulatory submissions
• Design controls and product lifecycle management
• Cross-functional collaboration and stakeholder management
• Risk assessment and mitigation planning
• Regulatory documentation and dossier preparation

Education

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