Regulatory Affairs Lead — Medical Devices

West Pharmaceutical Services / Progressive Medical; Exton (PA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Community involvement

Continuous learning & development

Generous PTO

Inclusive culture

Job summary

West Pharmaceutical Services seeks a Regulatory Affairs Senior Specialist to influence regulatory processes, author and review global submissions, and mentor team members across regions. The role focuses on timely, compliant deliverables for medical devices and pharmaceuticals, working with QA and R&D to ensure file accuracy.

Hybrid position requiring onsite presence at least 3 days per week, with opportunities to lead regulatory strategies and interact with agency personnel. 10% travel expected.

Qualifications

• Bachelor’s or Master’s degree in science, math, engineering, or related discipline or equivalent experience.
• Minimum years: 5 years for Bachelor’s; 3 years for Master’s/PhD in medical device/pharma/regulatory fields.

Responsibilities

• Develop medical device regulatory strategies for global approvals.
• Author/review US/EU/Asia submissions and post-market updates.
• Provide leadership to development teams on regulatory issues.

Skills

Regulatory experience

RAC certification

Global submissions

Regulatory leadership

Education

Bachelor/Master in science/engineering

Tools

MS Word

MS Excel

MS PowerPoint

Master Control

SharePoint

MS Teams

Job description

West Pharmaceutical Services seeks a Regulatory Affairs Senior Specialist to influence regulatory processes, author and review global submissions, and mentor team members across regions. The role focuses on timely, compliant deliverables for medical devices and pharmaceuticals, working with QA and R&D to ensure file accuracy.

Hybrid position requiring onsite presence at least 3 days per week, with opportunities to lead regulatory strategies and interact with agency personnel. 10% travel expected.