Sr. Specialist, Regulatory Project Management

Regulatory Project Management at West requires leading regulatory execution for a global portfolio of medical devices, combination products, SaMDs, and packaging components. The Senior Specialist partners with Regulatory Affairs Leads and cross-functional SMEs to drive deliverables across development, submission, approval, and post-market lifecycle. Responsibilities include developing and managing integrated regulatory plans and timelines, coordinating global filings and responses, aligning regulatory strategy with technical deliverables, applying design controls and risk management, and supporting interactions with health authorities, notified bodies, and external partners. The role emphasizes independent work in a fast-paced environment, strong communication, and ongoing continuous improvement of PM tools, templates, and metrics. The position requires a Bachelor’s degree in engineering/science/regulatory affairs (advanced degree preferred) with multiple years of medical device or combination product experience, familiarity with FDA QSR/QMSR, EU MDR, ISO 13485, and experience with regulatory submissions and lifecycle management. The role is Hybrid with at least 3 onsite days per week in Exton, PA, US.