Teams at Viatris

Lead a Human Factors/User Interface team for medical devices and drug-device combination products. Translate user needs into design inputs, oversee formative and summative HF studies (including comparative use), ensure regulatory compliance and risk management, standardize documentation, manage vendors, collaborate cross-functionally, and mentor staff to deliver inspection-ready usability evidence supporting development and submissions.

Lead risk management for medical devices and combination products across the product lifecycle. Develop and maintain Risk Management Files, perform FMEA/FTA/Medical Hazard Analyses, support regulatory submissions, assess post-market data, and drive RM process improvements while collaborating with Quality, Clinical, and Pharmacovigilance stakeholders.

The Senior Specialist will oversee global regulatory operations, ensuring compliance with EU regulations, managing data governance, and leading process improvements within regulatory initiatives.