Hybrid Senior Regulatory Project Manager (Medical Devices)

West Pharmaceutical Services; Exton (PA); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Opportunities for lifelong learning

Health programs for employees and families

Job summary

West Pharmaceutical Services, located in Exton, Pennsylvania, is hiring a Senior Specialist in Regulatory Project Management. This hybrid role involves leading regulatory project execution across medical devices and ensuring compliance with FDA and EU regulations.

The ideal candidate will have at least 5 years' experience in the medical device industry, strong project management skills, and proven communication abilities. Working in a collaborative environment, you'll support the lifecycle of regulatory submissions while contributing to a healthier community and environment.

Qualifications

• 5+ years of experience in medical device or combination product environments.
• Working knowledge of FDA and EU MDR regulations.
• Experience with Class II or Class III medical devices.

Responsibilities

• Lead execution for regulatory project management of medical devices.
• Develop and manage integrated regulatory project plans.
• Coordinate preparation and submission of regulatory filings.

Skills

Regulatory project management

Communication skills

Medical device development

Project management capability

Education

Bachelor's degree in engineering or related field

Advanced degree preferred

Tools

Microsoft Office Suite

Regulatory project management tools

Job description

West Pharmaceutical Services, located in Exton, Pennsylvania, is hiring a Senior Specialist in Regulatory Project Management. This hybrid role involves leading regulatory project execution across medical devices and ensuring compliance with FDA and EU regulations.

The ideal candidate will have at least 5 years' experience in the medical device industry, strong project management skills, and proven communication abilities. Working in a collaborative environment, you'll support the lifecycle of regulatory submissions while contributing to a healthier community and environment.