Research Scientist II – Extractables & Leachables (E&L) Team Lead

Location: Braine-l'Alleud, Belgium

Company

hirify.global is a global healthcare company developing medical devices, pharmaceutical products, and combination products focused on improving patient outcomes.

What you will do

• Lead and develop a team of E&L Study Directors.
• Set the strategic direction for Extractables & Leachables programs across medical devices, pharmaceutical products, and combination products.
• Partner with R&D, Toxicology, Regulatory Affairs, Quality, Manufacturing, and external laboratories on product development, lifecycle management, and regulatory submissions.
• Review and approve study designs, protocols, technical assessments, and reports.
• Guide complex scientific, regulatory, risk-management, and compliance decisions.
• Represent hirify.global in regulatory interactions, audits, inspections, and customer discussions while improving E&L capabilities and operational efficiency.

Requirements

• Proven experience leading and developing technical or scientific teams.
• Strong experience with Extractables & Leachables programs and the use of E&L data in regulatory submissions.
• Ability to translate complex scientific findings into clear business and regulatory recommendations.
• Experience influencing stakeholders across multiple functions and organizational levels.
• Strong strategic thinking, decision-making, communication, and multi-project resource-management skills.

Nice to have

• Experience with ISO 10993-18, USP <1663>, USP <1664>, and related regulatory guidance.
• Experience in medical devices, pharmaceuticals, or combination products.
• Knowledge of toxicology, biocompatibility, mass spectrometry, or advanced data interpretation.

Culture & Benefits

• Work on a diverse E&L portfolio within a global healthcare organization.
• Collaborate with experts across global R&D and partner functions.
• Influence product development programs and regulatory strategy.
• Develop scientific leadership and organizational capabilities.
• Contribute to products and therapies that support patients worldwide.