Regulatory Affairs Lead, Medical Devices (Hybrid)

West Pharmaceutical Services / Progressive Medical; Scottsdale (AZ); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Generous PTO

Global opportunities

Inclusive culture

Recognition & rewards

Job summary

West Pharmaceutical Services, Inc. seeks a Principal Specialist, Regulatory Affairs (Medical Devices) to influence regulatory processes and prepare global submissions, including Premarket Notifications and CE/Canada submissions. You will mentor team members and support regulatory approvals beyond US/EU for marketed products.

The role requires 8+ years of regulatory experience in medical devices or combination products, strong writing, and leadership abilities in a globally distributed team.

Qualifications

• Bachelor’s degree in science, engineering, or life sciences required.
• Minimum 8 years related regulatory experience required.
• Medical device or combination product regulatory experience preferred.

Responsibilities

• Develop regulatory strategies for medical devices and safety systems.
• Prepare US, EU and international submissions for new products and changes.
• Mentor RA team and support global regulatory approvals.

Skills

Regulatory strategy

Regulatory submissions

Communication

International regulatory

Documentation writing

Negotiation

Leadership

Multitasking

Education

Bachelor's degree in science/engineering

Tools

MS Word

MS Excel

MS Teams

MS PowerPoint

MasterControl

Adobe

SharePoint

Job description

West Pharmaceutical Services, Inc. seeks a Principal Specialist, Regulatory Affairs (Medical Devices) to influence regulatory processes and prepare global submissions, including Premarket Notifications and CE/Canada submissions. You will mentor team members and support regulatory approvals beyond US/EU for marketed products.

The role requires 8+ years of regulatory experience in medical devices or combination products, strong writing, and leadership abilities in a globally distributed team.