At Amazon, we're working to be the most customer-centric company on earth and to grow in a safe environment for both our Customers and our associates. To get there, we need exceptionally talented, bright, dynamic and driven people. If you'd like to help us build the place to find and buy anything online, this is your chance to make history.
We are looking for a Healthcare Program Manager to join the Restricted Products- Medical Device team.
Our vision for Restricted Products is to support Amazon’s mission of offering the widest selection of products available, while ensuring the safety and compliance of the products listed on Amazon websites. We are looking for a dynamic, organized self-starter to support our Professional Healthcare Program. This is an exciting opportunity to work in a highly visible space and be part of a vibrant and fast-growing company!
Based on input from Legal and internal business counterparts, you will support the Professional Healthcare Program to ensure compliance with regulations and internal policies. An eye for detail will make you successful at this job.
High Level Summary of Deliverables:
§ Complete and submit state license applications for relevant sites
§ Perform customer license verification
§ Support selling partner qualification activities
§ Review, interpret and evaluate medical device listings to ensure compliance with relevant medical device regulations, as defined.
§ Provide regulatory guidance and answer compliance-related questions regarding medical devices, in accordance with emerging/new regulations.
§ Provide compliance recommendations by conducting research, advising of upcoming regulations, and evaluating the overall impact on the business.
§ Work alongside business teams to identify regulatory requirements for product, per the defined business requirements to meet compliance standards and to ensure product safety.
§ Maintain documents and databases for state board of pharmacy licensing requirements
§ Design and create metrics and reporting criteria to deliver to the business teams.
§ Bachelor’s Degree
§ 5+ years of experience working in a regulated environment reviewing and applying FDA and international regulations for compliance
§ Experience in quality assurance for operational and distribution workflow
§ Demonstrated collaborative skills and ability to work well within a team, including adherence to core values and dynamic corporate culture
§ Ability to work under time pressure and meet performance goals
§ Exceptional organizational skills, ability to work independently and autonomously
§ Ability to understand, troubleshoot and describe complex technical processes and issues
§Self-motivated with critical attention to detail, deadlines and reporting
§ Demonstrated skill and passion for problem solving and operational excellence
§ Master’s Degree in regulatory affairs, engineering, operations or similar graduate degree such as a law degree.
§ A sound understanding of web technologies and database structures
§ Experience in supplier qualification
Amazon is an Equal Opportunity-Affirmative Action Employer - Minority/Female/Disability/Veteran/Gender Identity/Sexual Orientation