Senior Regulatory Affairs Lead — Medical Devices (Hybrid)

West Pharmaceutical Services, Inc; Exton (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

West Pharmaceutical Services, Inc. is seeking a Senior Specialist, Regulatory Affairs for Medical Devices. The role focuses on developing regulatory strategies, authoring and reviewing global submissions, and supporting post‑market activities with cross‑functional teams in a hybrid work environment.

You will mentor staff, liaise with agencies, and maintain compliance with 21 CFR 820/ISO 13485 while coordinating with R&D and QA for timely approvals.

Qualifications

• Bachelor’s with minimum 5 years; Master’s/PhD with minimum 3 years of medical device, pharmaceutical or regulatory experience.
• Experience authoring and reviewing regulatory submissions across multiple regions.

Responsibilities

• Develop and implement regulatory strategies for medical devices and ensure timely approvals.
• Author and review US/EU/China submissions and post‑market updates as required.
• Mentor team members and ensure compliance with regulations and company policies.
• Maintain regulatory databases and write/update SOPs and work instructions.
• Communicate project progress and alignment with RA management and customers.

Skills

Regulatory affairs

Leadership

Communication

Project management

Education

Bachelor’s/Master’s/PhD in science, math, engineering or related discipline

Tools

MS Word

MS Excel

MS PowerPoint

Master Control

SharePoint

MS Teams

Job description

West Pharmaceutical Services, Inc. is seeking a Senior Specialist, Regulatory Affairs for Medical Devices. The role focuses on developing regulatory strategies, authoring and reviewing global submissions, and supporting post‑market activities with cross‑functional teams in a hybrid work environment.

You will mentor staff, liaise with agencies, and maintain compliance with 21 CFR 820/ISO 13485 while coordinating with R&D and QA for timely approvals.