BIOTRONIK · 19 hours ago
Compliance Monitoring and Program Manager
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management. The Compliance Monitoring and Program Manager will enhance BIOTRONIK's Compliance Program and serve as a key compliance contact for industry associations and governmental agencies, overseeing compliance monitoring and providing guidance to various teams.
BiotechnologyHealthcareHealth CareMedical
Responsibilities
Oversee and execute BIOTRONIK, Inc.’s Compliance Monitoring Program including the planning, preparation, execution and review of all live monitoring and document review activities, as well as managing the compliance monitoring support team
Oversee and execute the on-going back office monitoring efforts
Assist in partnership with the VP, Compliance & Risk Management and Sr. Compliance Manager the annual Risk Assessment efforts for BIOTRONIK, Inc
Provide consistent and thoughtful compliance guidance to applicable functional teams and sales employees
Lead remediation of issues identified in monitoring and investigations including identifying compliance gaps and root cause and developing and implementing corrective action
Design in collaboration with Compliance Management and execute with applicable compliance team support quarterly Monitoring Sub-Committee meetings and Incidence of Non-Compliance Meetings
Manage direct reports and mentor all levels of staff
Serve as a key document collector for 3rd party and internal auditors as well as a point of contact for questions
Update compliance policies and procedures as necessary
On occasion, last minute travel may arise depending on time sensitive compliance matters
Review potential conflicts of interest and incidents of non-compliance and conduct investigations as necessary with oversight from VP, Compliance & Risk Management
Provide advice and assist Transparency team in annual filing as requested
Act as Compliance reviewer for promotional and educational materials as needed
Review grant requests as a member of the Financial Grant Committee
Deliver live training to all levels of BIOTRONIK personnel and assist with launch of online training courses
Assist with screening processes and help with applicable remediation
Act as Compliance reviewer for Needs Assessments and HCP engagement requests
Drive the development, implementation, and continuous improvement of an effective Ethics & Compliance Program
Perform other duties as assigned
Be responsive when sales and functional needs arise
Qualification
Required
Bachelor's Degree is required. Relevant fields are preferred but will consider all majors
At least 4-6 years of progressive Healthcare Compliance experience with at least 2 years being in a leadership position
Ability to work in a very fast paced medical device sector
Ability to modify work priorities as issues arise
Ability to travel
Ability to navigate in a cross-functional environment
Experience with governmental reporting
Strong compliance monitoring and/or audit experience
Strong managerial and leadership skills
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
Experience conducting investigations, determining root cause, and driving corrective actions
Strong analytical and decision-making skills and confidence providing guidance to business stakeholders
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
Demonstrated ability to lead compliance projects 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, Concur, Salesforce) or business intelligence/data analysis tools is a plus
Strong integrity/ethics and commitment to excellence
Preferred
Experience working in the medical device industry
Significant experience leading cross-functional initiatives
Experience working with or on governmental based projects
Advanced degree (e.g. Master's degree in health-related discipline) and/or certification (e.g. CCEP)
Company
BIOTRONIK
Biotronik is a privately held multinational biomedical technology company headquartered in Berlin, Germany.
Funding
Current Stage
Late StageLeadership Team
Recent News
2026-02-05
2026-01-23
2025-12-01
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