Regulatory Affairs Director (Healthtech)

TL;DR

Regulatory Affairs Director (Healthtech): Translating global regulatory strategy into execution across programs, regions, and service lines with an accent on Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data. Focus on scaling global regulatory capabilities, managing complex portfolios, and leading cross-functional teams.

Location: Hybrid (Amsterdam, Netherlands)

Company

hirify.global is a global health tech company dedicated to breaking down barriers for patients seeking treatment options through an AI-powered technology platform.

What you will do

• Translate company and RA/PV strategy into clear regulatory plans across programs and regions.
• Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives.
• Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines and quality standards.
• Lead, coach, and develop a team of Regulatory Affairs Managers and senior team members.
• Partner with Program Management, Medical Affairs, Quality Assurance, and Supply Chain to embed regulatory input into delivery.
• Standardize regulatory processes and act as a senior point of contact for clients and Health Authorities.

Requirements

• Advanced degree in life sciences, pharmacy, or a related field.
• Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments.
• Proven experience managing multiple programs and complex regulatory portfolios.
• Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar).
• Demonstrated leadership experience managing teams and developing talent.
• Excellent stakeholder management and communication skills.

Culture & Benefits

• Equal Opportunity Employer committed to cultivating a diverse and inclusive workplace.
• Culture where difference and diversity are protected and celebrated.
• Supportive environment focused on enabling team members to be their best selves.