Sr. Program Manager, FDA Compliance, D2AS Device Safety & Compliance
Are you relentless in the pursuit of top-performance, eliminating waste, drafting detailed new policy, identifying root causes and implementing creative and scalable process improvements? Are you an exceptional senior program manager with proven leadership skills? Does the thought of scaling a mature yet slightly ambiguous, multifaceted regulatory compliance program excite you? If so, you may have what it takes to succeed within D2AS DSC.
DSC's four main programs detect, assess and route customer facing concerns that carry a potential risk to the Amazon brand, including, but not limited to, Device Safety, FDA Compliance, Device Recovery and Right to Repair concerns.
The Food and Drug Administration (FDA) Compliance Sr.
PM sets the vision, direction, and roadmap for the FDA regulatory program governing policy for all of Amazon's 1P medical devices.
Work is both tactical and strategic in that you will be setting the program and policy that DSC and ECR Operations teams execute against.
You will own and manage the lifecycle of this and other complex initiatives.
You will unblock teams across vertices and increase the speed of delivery results while balancing D2, Devices Org, and legal priorities.
Must be able to force multiply and forge a self-sourcing path forward in difficult situations while making appropriate trade-offs between short-term vs.
long-term needs.
Ability to generate performance measures, KPIs, and ROI a must.
Key job responsibilitieso You manage complex initiatives, delivering critical solutions, significant improvements, new mechanisms, or deprecating processes that are no longer needed.
These efforts require you to work with multiple teams in and/or across organizations.
o You are accountable for the overall strategy of a large program.
You successfully manage all stages (from concept to delivery).
Your program meets challenging business goals and/or shows measurable improvements in your customer's experience, business or employee efficiency or execution, compliance adherence, financial or other metrics, etc.
o You understand the interdependencies of the business problems you help solve (e.
g.
, aligned workflows, customer requirements, process limitations, legal and compliance requirements, program support, etc.
).
You influence team priorities and business strategy through data-driven contributions.
You are able to make a case for project priorities, resource allocation, and/or appropriate program adoption, to achieve a desired business outcome, resolve a deficiency, or unblock delivery.
o You communicate ideas effectively, verbally and in writing, to a wide range of audiences including Directors and VPs.
You foster a constructive dialogue, harmonize discordant views, and lead the resolution of contentious issues (build consensus).
You partner successfully with customers, stakeholders, and engineering teams.
o Your program management practices set a great example to others.
You routinely and efficiently deliver the right things.
You define clear goals and objectives.
You drive crisp decisions in your program area about what projects move forward and in what priority order.
You proactively identify risks and bring them to the attention of your team and stakeholders with plans for mitigation before they become roadblocks.
o You are a simplifier.
You judiciously add, refine, and remove procedures.
By applying project management best practices, you increase the productivity and effectiveness of the teams you work with.
o You actively participate in the hiring process as well as mentor others - improving their skills and ability to get things done.
We are open to hiring candidates to work out of one of the following locations:
Arlington, VA, USA Nashville, TN, USA Seattle, WA, USA.
Estimated Salary: $20 to $28 per hour based on qualifications.
DSC's four main programs detect, assess and route customer facing concerns that carry a potential risk to the Amazon brand, including, but not limited to, Device Safety, FDA Compliance, Device Recovery and Right to Repair concerns.
The Food and Drug Administration (FDA) Compliance Sr.
PM sets the vision, direction, and roadmap for the FDA regulatory program governing policy for all of Amazon's 1P medical devices.
Work is both tactical and strategic in that you will be setting the program and policy that DSC and ECR Operations teams execute against.
You will own and manage the lifecycle of this and other complex initiatives.
You will unblock teams across vertices and increase the speed of delivery results while balancing D2, Devices Org, and legal priorities.
Must be able to force multiply and forge a self-sourcing path forward in difficult situations while making appropriate trade-offs between short-term vs.
long-term needs.
Ability to generate performance measures, KPIs, and ROI a must.
Key job responsibilitieso You manage complex initiatives, delivering critical solutions, significant improvements, new mechanisms, or deprecating processes that are no longer needed.
These efforts require you to work with multiple teams in and/or across organizations.
o You are accountable for the overall strategy of a large program.
You successfully manage all stages (from concept to delivery).
Your program meets challenging business goals and/or shows measurable improvements in your customer's experience, business or employee efficiency or execution, compliance adherence, financial or other metrics, etc.
o You understand the interdependencies of the business problems you help solve (e.
g.
, aligned workflows, customer requirements, process limitations, legal and compliance requirements, program support, etc.
).
You influence team priorities and business strategy through data-driven contributions.
You are able to make a case for project priorities, resource allocation, and/or appropriate program adoption, to achieve a desired business outcome, resolve a deficiency, or unblock delivery.
o You communicate ideas effectively, verbally and in writing, to a wide range of audiences including Directors and VPs.
You foster a constructive dialogue, harmonize discordant views, and lead the resolution of contentious issues (build consensus).
You partner successfully with customers, stakeholders, and engineering teams.
o Your program management practices set a great example to others.
You routinely and efficiently deliver the right things.
You define clear goals and objectives.
You drive crisp decisions in your program area about what projects move forward and in what priority order.
You proactively identify risks and bring them to the attention of your team and stakeholders with plans for mitigation before they become roadblocks.
o You are a simplifier.
You judiciously add, refine, and remove procedures.
By applying project management best practices, you increase the productivity and effectiveness of the teams you work with.
o You actively participate in the hiring process as well as mentor others - improving their skills and ability to get things done.
We are open to hiring candidates to work out of one of the following locations:
Arlington, VA, USA Nashville, TN, USA Seattle, WA, USA.
Estimated Salary: $20 to $28 per hour based on qualifications.
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