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Compliance
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200001H9 Requisition #
Careers that Change Lives

This role will report to a Sr. Compliance Director  and will manage, oversee and mitigate risks associated with US scientific integrity; establish policies and processes to ensure effective oversight and management of scientific integrity related risks, including relative to conflict of interest (e.g., royalty earners, collaborative research, clinical research), ERP and off-label program and processes; remediation and escalation of relevant issues related to scientific integrity; and, manage and execute on all key elements of US Off-label program for all US products, including conducting Product Risk Assessments and Product Risk Mitigation Plans.

This position can reside in Mounds View, MN, Memphis, TN, Boulder/Louisville, CO or Irvine, CA.

A Day in the Life


Responsibilities may include the following and other duties may be assigned.

  • Individual contributor and Subject Matter Expert, who acts independently with limited oversight, to manage and advise on compliance questions, programs and policies related to US scientific integrity risks (including cross-border activity) including:
  • Collaborate with Off Label Team, including relative to Product Risk Assessments (PRAs), Risk Mitigation Plans (RMPs), overall program management (e.g., faculty non-conformance, monitoring plan, action implementation) 
  • Manage and guide on ERP process and ERP compliance related questions
  • Consult on COI issues arising from other HCP engagement activities (e.g., Medical education faculty, $150K cap process)
  • Advise on compliance questions related to sponsored and collaborative research 
  • Individual contributor who manages with little or no supervision key elements of off-label risk mitigation program for all US products, including:
    • Oversee review of current Product Risk Assessments (PRAs)
    • Identify need for and oversee new PRAs
    • Manage current Risk Mitigation Plans (RMPs)
    • Identify need for and develop new RMPs
    • Manage action plans for all RMPs
    • Serve as Subject Matter Expert and advise on US policy/process related to off-label risk
    • Provide input to Global OEC and Legal Regulatory on off-label risk mitigation
    • Collaborate with A&M team to ensure effective monitoring activities to mitigate off-label risk (e.g., live and retro monitoring)
  • Business Conduct policy interpretation (e.g., royalty earners and clinical research engagement)
  • Recommendations for monitoring risk area
  • Recommendations for training, communication and education
  • Recommendations for program changes based on internal and external environment
  • Develop and implement solutions to complex problems and/or make moderate to significant improvements of processes, systems, or products independent to enhance compliance program performance.  
  • Problems and issues faced are difficult, moderately complex, or undefined and may require detailed information gather, analysis, and investigation.  
  • Anticipate and drive necessary strategies, processes and policy changes to account for shifts in the regulatory enforcement environment and/or changes to the business model.
  • Assist with risk assessment relative to scientific integrity related risks, prioritizing compliance issues based on relevant risk profiles.  When compliance issues are identified, work with business partners to generate new ideas to enable compliance solutions to business objectives.  
  • Design modifications to existing compliance programs, processes, standards, training, or risk mitigation activities based on subject matter expertise; business or compliance objectives; and inputs from Group Compliance or Corporate Compliance senior leadership.  
  • Develop and implement project plans to achieve compliance program objectives, often leveraging and influencing others as part of a cross-functional team.  Activities result in a significant impact on compliance program results. 
  • Provide expert knowledge and application of legal/regulatory requirements, including AdvaMed and other applicable industry codes and/or guidance across multiple subject matters.
  • Benchmark with other Medtronic business units and/or other outside companies to determine “best-in-class” processes and incorporate as deemed appropriate.
  • Project management and/or risk management experience for multiple competing projects and/or programs.
  • Provide subject matter expertise for key operational systems, databases, and tools which provide key compliance controls for compliance program.  
  • Provide suggestions, feedback to system administrators on ways to improve the overall end-user experience to enhance compliance controls.
  • Independently provide strategic and complex guidance as needed to internal functions with moderate financial, reputational, or compliance implications.
  • Serve as team lead to junior level staff and manage major/compliance projects involving delegation of work and review of work product and ensure that accurate and comprehensive documentation of compliance plan activities in risk areas are created, maintained and tracked.  

 


Must Have: Minimum Requirements
  • Bachelor’s degree 
  • Minimum 5 years of compliance, regulatory, clinical, quality or legal experience in a regulated environment with a bachelor’s degree; or, 3+ years with an advanced degree
Nice to Have
  • Ability to work well under pressure and maintain positive, enthusiastic attitude.
  • Ability to work in a constantly-changing, fast-paced environment and adeptly manage numerous competing priorities.
  • Compliance experience in healthcare, medical device, or pharmaceutical manufacturing. 
  • Understanding of risks, policies, procedures related to scientific integrity. 
  • Understanding of regulatory framework and application of regulations to internal policies and processes.
  • Understanding of external risk environment and enforcement.
  • Work effectively in a team environment in a leadership capacity and build strong working relationships, involving multiple business functions, units, and/or geographies.  
  • Very strong organizational, process and project management skills; ability to drive and champion organizational change programs. 
  • Highly developed influence management skills, including the proven ability to organize, communicate, and manage issues to a variety of levels of individuals within the organization.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. 

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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