Technical Specialist
Switzerland
Job Description
Technical Specialist
Zuchwil, Solothurn
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
Information at a Glance