Coordination of the preparation of regulatory documents and dossiers for complex products
Primary contact for external stakeholders and regulatory authorities
Anticipation of and adaptation to changes in the regulatory environment
Promote collaboration and provide leadership within the team

Degree in Life Sciences, Data Science, or a related field (BSc, MSc, or PhD)
Several years of professional experience in Regulatory Affairs (3–8 years, depending on degree)
Expert knowledge of CLIA regulations, EU IVDR, and US requirements
Knowledge of international markets, especially APAC, is advantageous
Experience working in project teams and product knowledge in the diagnostics field
Fluent English skills (C2 level) — spoken and written
Self-driven with a focus on continuous improvement

Regulatory Affairs Manager

Key skills