Senior Global Regulatory Strategist - Medical Devices

Amazon Inc.; Factoria (WA); On-site; USD 149,000 - 201,000; Full time

Job summary

Amazon.com Services LLC in Bellevue, WA is seeking a Sr. Regulatory Affairs Specialist to help build global regulatory strategies for medical devices within MD-OCC. You will collaborate with product teams and quality to ensure compliance throughout development and post-market.

The role requires 7+ years in regulatory affairs, experience with FDA submissions and international registrations, and strong leadership. You will interface with FDA and Notified Bodies and support audits and licensing.

Qualifications

• 7+ years of experience working with engineering teams
• Experience preparing regulatory submissions and reports
• Knowledge of 21 CFR 820, ISO 13485 and related standards
• Experience with Class II/III medical devices
• Strong analytical and communication skills
• Bachelor’s degree in a scientific field

Responsibilities

• Act as regulatory representative on core product development teams
• Develop global regulatory strategies for new and modified products
• Prepare and submit regulatory submissions to health authorities
• Interpret regulatory requirements for product portfolio
• Collaborate with quality systems to maintain regulatory compliance
• Maintain licenses, registrations, and listings
• Support product release and audits
• Interface with FDA and Notified Bodies

Skills

Regulatory strategy development

FDA submissions knowledge

Cross-functional leadership

Regulatory filings and reports

Excellent communication

Project management

Education

Bachelor’s degree in Biomedical Engineering / Life Sciences / Biology

Job description

Amazon.com Services LLC in Bellevue, WA is seeking a Sr. Regulatory Affairs Specialist to help build global regulatory strategies for medical devices within MD-OCC. You will collaborate with product teams and quality to ensure compliance throughout development and post-market.

The role requires 7+ years in regulatory affairs, experience with FDA submissions and international registrations, and strong leadership. You will interface with FDA and Notified Bodies and support audits and licensing.