Product Safety Policy Expert, Regulatory Intelligence, Safety, and Compliance

Amazon Inc.; Seattle (WA); On-site; USD 121,000 - 164,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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.

Skills

Regulatory compliance

Risk management

Policy analysis

Stakeholder communication

Microsoft Office

Education

Bachelor's degree or equivalent

Master's degree or equivalent

Tools

Lean Six Sigma

Job description

Description

The Regulatory Intelligence, Safety and Compliance (RISC) team's charter is to protect Amazon customers from products that are illegal, illegally marketed, unsafe, or otherwise prohibited by Amazon policies.

Description

The Regulatory Intelligence, Safety and Compliance (RISC) team's charter is to protect Amazon customers from products that are illegal, illegally marketed, unsafe, or otherwise prohibited by Amazon policies. The Product Safety policy expert will own analysis and risk assessment activities required to formulate WW product safety polices. They will serve as our serves as the Medical Device subject matter expert, providing guidance on complex policy decisions related to product safety for products such as mobility aids, diagnostic devices, other durable medical equipment. The role requires industry expert of relevant regulatory frameworks, including but not limited to medical device regulations such as US Food & Drug Administration, Health Canada, EU Medical Device Regulation, ANVISA (Brazil) and applicable industry standards.

Key job responsibilities

• Monitor and analyze emerging medical device regulations and associated customer safety risks globally.


• Make high-judgement decisions regarding policies related to product safety in order to meet world wide regulatory obligations and enhance customer safety.


• Perform analysis of data from a variety of sources to identify possible risk indicators to support policy decisions.


• Coordinate with Legal teams to integrate legal and safety analysis in support of key policy decisions.


• Work with a wide range of cross-functional teams to communicate Amazon's safety and compliance strategies to stakeholders.


• Communicate regularly with leadership and ensure consistent reporting against commitments.


• Drafting and presenting strategies to enhance risk management practices, including analysis of industry practice.


• Stay current with new technologies and safety testing standards in the medical device space.

Basic Qualifications

• 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

Preferred Qualifications

• Project Management Professional (PMP) or equivalent certification


• Experience leveraging technology and implementing lean principles / Six Sigma methodologies to drive process improvements or equivalent


• Master's degree or equivalent

Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.

Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.

USA, VA, Arlington - 121,200.00 - 163,900.00 USD annually

USA, WA, Seattle - 121,200.00 - 163,900.00 USD annually

Company - Amazon.com Services LLC

Job ID: A10586945