Global Medical Device Policy & Risk Lead

Amazon Inc.; Seattle (WA); In loco; USD 121.000 - 164.000; Tempo pieno

Descrizione del lavoro

Amazon.com Services LLC is seeking a policy expert in Regulatory Intelligence, Safety and Compliance (RISC) to own analysis and risk assessment activities for WW product safety policies. The role covers regulatory frameworks for medical devices and related safety decisions across global markets, including the US FDA, Health Canada, EU MDR, and others.

The position requires industry expertise and collaboration with Legal and cross-functional teams to implement safety policies and reporting.

Competenze

• 8+ years of compliance, audit or risk management experience.
• Knowledge of Microsoft Office products and applications at an advanced level.
• Bachelor's degree or equivalent

Mansioni

• Monitor and analyze emerging medical device regulations and associated customer safety risks globally.
• Make high-judgement decisions regarding policies related to product safety to meet worldwide regulatory obligations.
• Perform analysis of data from various sources to identify risk indicators for policy decisions.
• Coordinate with Legal teams to integrate legal and safety analysis for key policy decisions.
• Work with cross-functional teams to communicate Amazon's safety and compliance strategies to stakeholders.
• Communicate regularly with leadership and report against commitments.
• Draft and present strategies to enhance risk management practices, including industry best practices.
• Stay current with new technologies and safety testing standards in the medical device space.

Conoscenze

Regulatory compliance

Risk management

Policy analysis

Stakeholder communication

Microsoft Office

Formazione

Bachelor's degree or equivalent

Master's degree or equivalent

Strumenti

Lean Six Sigma

Descrizione del lavoro

Amazon.com Services LLC is seeking a policy expert in Regulatory Intelligence, Safety and Compliance (RISC) to own analysis and risk assessment activities for WW product safety policies. The role covers regulatory frameworks for medical devices and related safety decisions across global markets, including the US FDA, Health Canada, EU MDR, and others.

The position requires industry expertise and collaboration with Legal and cross-functional teams to implement safety policies and reporting.