Senior Regulatory Project Lead – Medical Devices

West Pharmaceutical Services / Progressive Medical; Exton (PA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

West Pharmaceutical Services is seeking a Senior Specialist, Regulatory Project Management to lead regulatory execution for a global portfolio of medical devices, combination products and SaMDs. The role partners with Regulatory Affairs Leads and cross‑functional SMEs to drive deliverables from development through post‑market lifecycle.

The successful candidate will bring expertise in medical device regulatory frameworks, project management, and lifecycle planning to ensure timely, compliant

Qualifications

• Experience supporting medical device regulatory activities across development, registration and lifecycle management.
• Knowledge of FDA/QMSR, EU MDR, ISO 13485 and global standards.

Responsibilities

• Lead regulatory project execution for medical devices, combination products, SaMD, and packaging throughout the lifecycle.
• Develop and manage integrated regulatory plans, timelines, dashboards and risk/issue logs.
• Coordinate global regulatory filings and information requests across regions.
• Collaborate with Regulatory Affairs Leads and cross‑functional SMEs for strategy and submission readiness.
• Support interactions with health authorities and notified bodies.

Skills

Regulatory project management

Regulatory affairs

Medical device knowledge

Cross-functional collaboration

FDA 510(k)

EU MDR

ISO 13485

Education

Bachelor’s degree in engineering/science/regulatory affairs

Tools

Microsoft Office Suite

Job description

West Pharmaceutical Services is seeking a Senior Specialist, Regulatory Project Management to lead regulatory execution for a global portfolio of medical devices, combination products and SaMDs. The role partners with Regulatory Affairs Leads and cross‑functional SMEs to drive deliverables from development through post‑market lifecycle.

The successful candidate will bring expertise in medical device regulatory frameworks, project management, and lifecycle planning to ensure timely, compliant