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

Amazon; Arlington (VA); Vor Ort; USD 121.000 - 164.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) matching

Paid time off

Parental leave

RSUs

Zusammenfassung

Amazon is seeking a policy expert for Product Safety within the Regulatory Intelligence, Safety and Compliance (RISC) team. You will own analysis and risk assessment to formulate worldwide product safety policies for medical devices and durable equipment, guiding decisions across regulatory frameworks including FDA and EU MDR.

Responsibilities include monitoring global regulations, coordinating with Legal, and communicating safety strategies across teams.

Qualifikationen

• 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.

Aufgaben

• 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 and enhance customer safety.
• Perform analysis of data from various sources to identify risk indicators to support policy decisions.
• Coordinate with Legal teams to integrate legal and safety analysis in support of key policy decisions.
• Work with cross-functional teams to communicate Amazon's safety and compliance strategies to stakeholders.
• Communicate regularly with leadership and ensure reporting against commitments.
• Draft strategies to enhance risk management practices and analyze industry practices.
• Stay current with new technologies and safety testing standards in the medical device space.

Kenntnisse

Risk management experience

MS Office advanced

Ausbildung

Bachelor's degree or equivalent

Master's degree or equivalent

Jobbeschreibung

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