Regulatory Manager (Medtech)

TL;DR

Regulatory Manager (Medtech): Managing regulatory development and submissions for clinical trials to ensure compliance with global regulations with an accent on the preparation of CTA/IND applications and strategic regulatory guidance. Focus on coordinating submissions to Regulatory Authorities and Ethics Committees, analyzing regulatory intelligence, and optimizing the clinical development life cycle.

Location: Remote (United States)

Salary: $106,000 - $151,000 USD

Company

hirify.global is a clinical solutions provider specializing in precision medicine and pharmaceutical drug development.

What you will do

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile and review applications for Regulatory Authorities, including CTA/IND, annual reports, and orphan designations.
• Develop and review submission documents for Regulatory Authorities and Ethics Committees to ensure compliance.
• Represent Global Regulatory Affairs in project team and business development meetings.
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
• Maintain project plans, trackers, and regulatory intelligence tools.

Requirements

• Must be based in the United States.
• Bachelor's degree in a scientific or healthcare discipline.
• 5+ years of relevant regulatory affairs experience.
• Knowledge of drug development processes and regulatory milestones for the US or EU.
• Expertise in IND/CTA submissions and Scientific Advice Procedures.
• Fluent English proficiency.

Nice to have

• Graduate or postgraduate degree.
• Basic understanding of financial management.

Culture & Benefits

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