Regulatory Affairs Consultant

Location: Santa Clarita, CA
Worksite: Onsite required
Pay: $60/HR + (DOE)
Duration: 12 month+ contract

About Us

The Ranger Group is a Professional Services Firm that partners with leading manufacturers in the Medical Device, Aerospace/Defense, Electronics and Industrial sectors. We focus on helping companies design and build intelligent products across engineering, regulatory affairs, clinical, QA, manufacturing and IT.

Regulatory Affairs Consultant

We are seeking an experienced Regulatory Affairs Consultant for a large medical device customer to support sustaining activities for Class III medical devices. This role will focus on assessing and managing regulatory impact of manufacturing and process changes to ensure continued compliance with global regulatory requirements.

Key Responsibilities

• Review, assess, and document regulatory impact of manufacturing, process, and validation changes
• Support change control activities, including regulatory strategy, submission impact assessments, and regulatory documentation updates.
• Provide regulatory input on process validation, revalidation, and verification activities for Class III devices.
• Collaborate with Quality, Manufacturing, and Engineering teams to ensure compliant implementation of changes.
• Support IDE-related activities as needed, including amendments and regulatory correspondence.

Required Qualifications

• Proven experience supporting Class III medical devices.
• Hands-on experience reviewing and assessing manufacturing and validation change orders
• Solid understanding of FDA regulations, Quality System Regulation (21 CFR 820), and change control processes.
• Experience supporting IDE submissions or amendments.