Compliance Manager, BIOTRONIK NEURO

Biotronik-posted about 2 months ago
Full-time • Mid Level
Remote • Lake Oswego, OR
5,001-10,000 employees
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As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day. The Compliance Manager of BIOTRONIK NEURO will build and drive key program elements and activities associated with the management and continuous improvement of BIOTRONIK NEURO's Compliance program. The Compliance Manager will operate in a multi-disciplinary and interdepartmental capacity, will enact controls, develop appropriate compliance processes and guidelines, and assure adherence, thereof and elevate employees' understanding of compliance. The Compliance Manager is a recognized subject matter expert, relied upon throughout the company, in various elements of BIOTRONIK NEURO's Compliance program. Reporting of the Compliance Manager position will be directly to the President.

  • Leveraging policies and procedures developed by BIOTRONIK, Inc.'s Compliance Program, manage and draft relevant Compliance policies for BIOTRONIK NEURO.
  • With support from the Legal Department, develop, conduct, and lead annual Risk Assessment efforts including anticipating and identifying areas of risk for the company, proactively identifying steps for remediation, and collaborating on metrics.
  • Create and execute, with support from the Legal Department, the Annual Compliance Monitoring plan leveraging results from the Risk Assessment.
  • Develop, lead and execute compliance training programs leveraging resources and materials developed by BIOTRONIK, Inc.'s Compliance Program.
  • With support from HR and Legal, participate and lead compliance investigations and conflict of interest reviews and remedial action efforts.
  • Respond to day-to-day Ethics & Compliance questions based on established policies and procedures.
  • Leveraging efforts and program materials from BIOTRONIK, Inc. design the compliance parameters around use of HCP consultants. Update as needed.
  • Lead interdepartmental initiatives and task forces related to compliance.
  • Create effective communications on compliance related topics to be sent periodically to applicable business functions.
  • 5+ years' experience in a compliance role; preference for a medical technology or pharmaceutical company, and demonstrated knowledge of applicable compliance regulations, standards, laws, and trends.
  • Direct experience with contracting with healthcare professionals.
  • Bachelor's Degree is required. Relevant fields are preferred but will consider all majors.
  • At least 3 years of experience within a medical device organization.
  • Core knowledge and understanding of applicable regulations, recent enforcement actions and trends (e.g. Corporate Integrity Agreements in the life science industry), and ethics & compliance best practices including:
  • AdvaMed Code of Ethics,
  • Anti-Kickback Statute
  • False Claims Act
  • Physician Payments Sunshine Act
  • Strong integrity/ethics and commitment to excellence.
  • Ability to navigate in a cross-functional environment
  • Strong data analysis interest and experience
  • Ability to tackle new projects and lead efforts and staff.
  • Experience conducting compliance investigations, determining root cause, and driving corrective actions.
  • Strong analytical and decision-making skills. Ability to absorb and analyze large amounts of information and make decisions by weighing evidence, alternatives, risks, etc. Data analysis and audit experience is a plus.
  • Ability to apply project management and change management techniques to internal projects.
  • Excellent communication skills, including the ability to communicate with high-level management, to influence others without authority when necessary, and to conduct contentious and critical investigative interviews.
  • Positive attitude and willingness to work as part of a team and mentor other team members.
  • Ability to work independently as needed.
  • Capacity to serve as a team leader and meet ambitious project milestones and objectives.
  • Strong organizational skills and attention to detail.
  • Proficient PC application skills, including knowledge of MS Excel, email systems, etc. Experience with enterprise systems (e.g. SAP, Oracle, Concur, Salesforce) or business intelligence/data analysis tools is a plus.
  • Experience working with other relevant life science or a healthcare industry.
  • Significant experience navigating a cross-functional environment or an advanced degree (e.g. Master's in health-related discipline degree) and/or certification (e.g. CCEP).
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