Amazon is looking for a Medical Regulatory Officer to help build their incremental testing capacity to deal with the COVID-19 pandemic according to a job posting on their website. The post says they are focused on protecting the health and safety of their employees while continuing to serve people who need their services more than ever.
Regular testing on a global scale across all industries would both help keep people safe and help get the economy back up and running, but more testing capacity than is currently available is needed. Amazon posted that “until we have an effective vaccine available in billions of doses, high-volume testing capacity would be of great help, but getting that done will take collective action by many different organizations.” Amazon has been building incremental testing capacity to deal with the COVID-19 pandemic. They are seeking an individual who has the experience to navigate existing regulatory waters but who also has the skills and savvy to chart ambiguous or new territory with local, state and national regulators for clinical diagnostics.
A few of the key responsibilities listed include:
- Identify existing areas of regulatory non-compliance risk and define strategies and projects to reduce that risk.
- Understand CLIA and FDA requirements, and ensure that these and other national and state standards are translated into working policies and processes.
- Coordinate expert stakeholder reviews of submissions to regulatory agencies and ensure that submissions and responses to agency questions are accurate and timely.
- Collaborate effectively across organizational departments (e.g., Medical Regulatory, Quality, Laboratory Operations, Field Operations, Public Policy, Legal) and enterprise lines of business (e.g., Amazon Care, Pharmacy, AWS, Alexa, Devices ) to determine regulatory needs and centralize/synchronize resources to serve those needs without unnecessary redundancy.
- Build a team to monitor changes in local, state and Federal/national regulations, and manage that team to drive revised or new process changes to maintain regulatory compliance.
- Keep other senior leaders informed of significant regulatory changes potentially affecting current operations and future strategy.
- Develop relationships with key regulatory agencies to enhance lines of communication, including appropriate collaborations to discuss novel processes or lines of business which do not fit comfortably within the existing regulatory framework.
- Serve as the preferred single point of contact for key regulators.
