Job Summary

• Provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products.
• Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies, including FDA, EMA/Competent Authorities under EU MDR, MHRA, PMDA, and other agencies as applicable.
• Advanced degree in a scientific or engineering discipline with 20+ years of industry experience, including 10+ years in Regulatory Affairs with demonstrated leadership in medical devices and/or drug-device combination products.

Matching Summary

Salary

Base: $238,000.00 - $374,000.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation

Skills & Requirements

Key Requirements

• Advanced degree in scientific or engineering discipline
• 20+ years industry experience
• 10+ years Regulatory Affairs experience
• Significant experience leading regulatory submissions
• Strong working knowledge of device/combination product regulations
• Demonstrates acceptable skills in regulatory strategy

Work Rights