Senior Regulatory Strategy Lead, Medical Devices

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

Job summary

Amazon Industrial Devices and Services is seeking a Sr. Regulatory Affairs Specialist to lead global regulatory strategy and submissions for medical devices.

The role requires hands-on FDA knowledge and experience across the product lifecycle, with collaboration across design, quality, and manufacturing teams. The successful candidate will build proactive regulatory programs, work with Notified Bodies and health authorities, and ensure compliance through all stages of development and post-market

Qualifications

• 7+ years of working directly with engineering teams
• 5+ years of technical product or program management experience
• 5+ years of technical program management with software teams
• Experience with regulatory filings and reports or equivalent
• Experience with design controls, risk management and product labeling compliance
• Experience communicating regulatory requirements to cross-functional teams

Responsibilities

• Act as regulatory representative on product development teams and advise on FDA registrations
• Develop global regulatory strategies for new or modified products
• Prepare and submit regulatory submissions to health agencies
• Interpret regulatory requirements related to product portfolio and quality systems
• Provide regulatory assessment for manufacturing changes and risk
• Review labeling, claims, and promotional material for compliance
• Plan and schedule activities to meet regulatory timelines
• Collaborate with quality leadership to maintain compliance and audits
• Maintain licenses, registrations, and listings for products
• Support product release processes and audits by regulators

Skills

Regulatory strategy

FDA submissions

Cross-functional leadership

Project management

Quality systems

Education

Bachelor’s Degree in Scientific discipline

Job description

Amazon Industrial Devices and Services is seeking a Sr. Regulatory Affairs Specialist to lead global regulatory strategy and submissions for medical devices.

The role requires hands-on FDA knowledge and experience across the product lifecycle, with collaboration across design, quality, and manufacturing teams. The successful candidate will build proactive regulatory programs, work with Notified Bodies and health authorities, and ensure compliance through all stages of development and post-market