Regulatory & Scientific Digitalisation Project Management Specialist (Medtech)

TL;DR

Regulatory & Scientific Digitalisation Project Management Specialist (Project Management): Leading strategic digital transformation initiatives to optimize regulatory processes for medicinal products with an accent on data-driven process optimization and end-to-end workflow digitalisation. Focus on bridging scientific expertise with IT solutions, eliminating process waste, and implementing Agile/LEAN methodologies.

Location: Amsterdam, Netherlands (relocation to take up duties is mandatory)

Salary: Net monthly 5,979.74 Euro

Company

The European Medicines Agency (hirify.global) promotes and protects public animal health in EU Member States by ensuring medicines on the EU market are safe and effective.

What you will do

• Lead end-to-end digital transformation projects from initial concept through to final implementation.
• Optimize regulatory workflows and eliminate waste using Agile, LEAN, or other delivery methodologies.
• Coordinate multidisciplinary teams consisting of business, data, IT specialists, and external vendors.
• Translate complex regulatory and scientific requirements into implementable digital solutions and backlogs.
• Manage project scope, KPIs, risks, and supplier contracts to ensure high-quality regulatory outcomes.
• Develop and improve the Agency's overall programme management capabilities and methodologies.

Requirements

• Full rights as a citizen of an EU Member State, Iceland, Liechtenstein or Norway.
• English proficiency at level C1 and another official EU language at level B2.
• University degree (minimum 3 years) and at least 3 years of professional experience.
• Proven experience in project management and/or data analytics.
• Extensive experience within regulatory or scientific activities related to medicine evaluation or monitoring.
• Experience leading major digital/process transformation initiatives.

Nice to have

• Experience implementing CRM systems for regulatory information management (e.g., IRIS).
• Certifications in PRINCE2, SAFe Agile, or Green Lean Six-Sigma.
• Knowledge of hirify.global structures, core processes, and the stakeholder landscape.
• Proficiency with Microsoft Project or Agile planning tools.

Culture & Benefits

• Initial 5-year renewable contract with a competitive tax-free salary.
• Comprehensive relocation assistance and expatriation/education allowances.
• Excellent health insurance scheme and retirement pension plan.
• Work-life balance with flexible working arrangements and teleworking options.
• Opportunity to perform meaningful work contributing to public health across Europe.