Corrections & Removals Expert

📋 Description

• Serve as subject matter expert for corrections and removals processes
• Apply regulatory and risk-based mindset to C&R process design
• Develop and maintain C&R process framework with leadership
• Identify process gaps and lead improvement implementations
• Manage structured C&R change request process
• Evaluate AI and digital tools for C&R efficiency

🎯 Requirements

• Bachelor's or Master's in Medical Sciences or related
• 5+ years experience in pharma, IVD, or medical devices
• Preferred 5 years in Corrections and Removals
• Knowledge of FDA, EU MDR, Health Canada regulations
• Strong analytical and problem-solving skills
• Legally authorized to work in the US without sponsorship

🎁 Benefits

• Comprehensive healthcare: medical, dental, vision
• Generous paid time off
• 401(k) with up to 7% company match
• Health Savings Account with company contribution
• Employee stock purchase plan
• Education reimbursement