The Ranger Group · 11 hours ago
Regulatory Affairs Consultant
Santa Clara, CA
Full-time
Onsite
Mid LevelThe Ranger Group is seeking an experienced Regulatory Affairs Consultant to support sustaining activities for Class III medical devices. This role focuses on managing regulatory impacts of manufacturing and process changes to ensure compliance with global regulatory requirements.
ConsultingIndustrial EngineeringManufacturing
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
Qualification
Required
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
Company
The Ranger Group
Ranger Group is an industrial engineering company that has expertise in various sectors such as aerospace, defense, energy, and electronics.
Founded in 2009
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase