Director, IVD Regulatory Consulting

TL;DR

Director, IVD Regulatory Consulting: Leading regulatory strategy and business development for in vitro diagnostics with an accent on global clearance processes and quality systems. Focus on designing actionable business solutions, managing high-level client relationships, and developing regulatory expertise within the team.

Location: Must be based in the United States

Salary: $162,000 - $243,000 USD

Company

hirify.global is a specialized services firm providing integrated research and regulatory solutions for the life sciences industry.

What you will do

• Direct global regulatory submission and approval processes for in vitro diagnostics.
• Design strategic regulatory approaches to optimize business outcomes for pharma and life science clients.
• Collaborate with external experts and internal teams to support research, development, and marketing authorization.
• Drive business development by leveraging professional networks and supporting client proposals.
• Provide subject matter expertise on regulatory compliance and strategic program positioning.
• Manage, mentor, and develop staff to ensure a scalable regulatory practice.

Requirements

• Must be based in the United States
• Bachelor’s degree in Life Sciences or equivalent experience.
• Minimum 5 years of consulting experience focused on regulatory affairs.
• Minimum 7 years of experience in medical device, pharmaceutical management, or clinical trial consulting.
• Proven experience managing staff and project teams.
• Strong business, financial, and scientific acumen.

Nice to have

• Master’s degree.

Culture & Benefits

• Comprehensive health insurance, life insurance, and disability benefits.
• Retirement savings benefits.
• Parental leave.
• Paid time off for vacation and sick leave.
• Discretionary annual bonus eligibility.