Job Summary

• The role involves leading device regulatory affairs strategies for autoinjector, inhalation, and other delivery system development programs while ensuring robust assessment of scientific content.
• Candidates must possess a demonstrated background in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits like 401(k), and paid holidays.

Matching Summary

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Key Requirements

• Bachelor's degree required; advanced degree preferred
• Minimum 10 years relevant experience for Bachelor's/Master's holders
• Subject matter expertise in combination product regulatory development
• Experience with IDE/IND/510(k) clearances and CE mark authorizations

Work Rights