Technical Specialist at HCLTech in Zuchwil, Solothurn, Switzerland

Job Summary

Responsible for planning, coordinating, and executing regulatory activities to ensure timely market access and continued compliance of medical devices, pharmaceuticals, or healthcare products. Collaborates with cross-functional teams to obtain regulatory approvals, maintain licenses, manage regulatory documentation, and support post-market compliance activities.

Key Responsibilities

Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and variations.Support global and regional regulatory submissions to health authorities.Track submission status and ensure timely responses to regulatory queries.Maintain regulatory licenses and establishment registrations

Skill Requirements

Knowledge of global regulatory frameworks (FDA, EU MDR/IVDR, CDSCO, ANVISA, PMDA, TGA, Health Canada, etc.).Regulatory submission lifecycle management.Labeling and compliance review.Regulatory intelligence and change impact assessment.Familiarity with Quality Management Systems (QMS), CAPA, and risk management.Proficiency in regulatory databases and document management systems.

Other Requirements