Credentialing Analyst
hims & hers
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 combination products and delivery systems
- Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
- Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations
- Identify and manage issues and opportunities that impact submissions 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
- Contribute to product development and lifecycle management planning and provide regulatory impact assessments for proposed product changes
- Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
- Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
- Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable
Requirements
- 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
- 5+ years of relevant medical device and/or combination product 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 development (including design controls), manufacturing processes, and regulatory requirements in major markets
- Working knowledge with technical/industry standards related to injection devices
- 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)
- May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities
