Senior Financial Analyst
Interwell Health
GRA Device Lead – Associate Director
Sanofi
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $147,000 - $212,333 per year
Job Level
Senior
About the role
- Serve as GRA Device Lead 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 DHTs 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
- Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation
- 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 business partners to enable successful regulatory outcomes
- Prepare, review and approve design control deliverables and contribute to product development and lifecycle management planning
- Provide regulatory impact assessments for proposed product changes and contribute to internal regulatory processes for DHTs
- May serve as Device Global Regulatory Lead (dGRL), leading Device GRT and representing GRA at internal governance committees
Requirements
- 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years of Device/DHTs regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
- Experience responding to Health Authority questions
- Experience preparing regulatory documentation and familiarity with standard submission processes
- Understanding of clinical development of medicinal products, device (including design controls), and manufacturing processes
- Familiarity with regulatory requirements in major markets
- Working knowledge of technical/industry standards (software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, usability)
- Ability to synthesize and critically analyze data from multiple sources
- 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
- Strategic thinking, initiative, change agent leadership and risk assessment proficiency
- Bachelor's degree in a scientific or engineering discipline (Graduate degree preferred)
- Strong written and verbal communication and influencing skills, with fluency in English
- Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)
