Director, IVD Regulatory Consulting

📋 Description

• Direct submission prep for global clearance of in vitro diagnostics.
• Design strategies for regulatory approvals, clearances, and post-market needs.
• Review and direct analytical/clinical protocols and reports for submissions.
• Identify and collaborate with external experts for regulatory support.
• Review and edit regulatory communications, submissions, and timelines.
• Apply quality systems to guide clients to market readiness.

🎯 Requirements

• Bachelor's degree in Life Sciences or equivalent
• Minimum 5 years of regulatory affairs consulting experience
• Minimum 7 years in medical device/pharma services consulting
• Strong written and verbal communication skills
• Strong leadership and team-building skills
• Direct experience with global regulatory and commercialization strategies

🎁 Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation