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$144k–$216k/yr
Full-time
bachelor degree, postgraduate degree
Medical, Dental, Vision, 401k matching
Posted 65d ago
~40 hrs/week
Responsibilities
Serve as the primary compliance advisor for MicroAire, implementing the Group compliance program and guiding HCP engagements and commercial activities. The role involves conducting risk assessments, managing investigations, and delivering targeted compliance training to personnel and third parties.
Requirements
Requires a bachelor's degree and at least 7 years of experience in healthcare compliance, legal, or regulatory roles within a highly regulated industry. Candidates must have deep knowledge of US laws like the Anti-Kickback Statute, False Claims Act, and the AdvaMed Code of Ethics.
Full job description
MicroAire Surgical Instruments LLC
As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.
Marmon Medical is seeking a Compliance Business Partner to serve as the embedded compliance leader and primary day-to-day compliance advisor for MicroAire. Reporting to the Chief Compliance Officer, Marmon Medical Group, this role will implement and operationalize the Group compliance program at MicroAire, advise on HCP engagements, grants and sponsorships, medical education, promotional and commercial activities, third-party relationships, training, monitoring, investigations, and risk mitigation. The ideal candidate is a pragmatic medical device compliance leader who can build trusted business partnerships, translate requirements into workable processes, and help the organization achieve business objectives with integrity and accountability.
Core Responsibilities
Business Advisory & Leadership Partnership
Serve as the primary compliance partner and advisor for MicroAire, providing practical, risk-based guidance to leadership and business functions.
Participate in MicroAire leadership forums as the primary compliance representative and help integrate ethics and compliance considerations into business planning and decision-making.
Build trusted relationships with Sales, Marketing, Medical Education, R&D, Regulatory Affairs, Quality Assurance, Human Resources, Finance, Legal, Operations, and International Business leaders.
Help the business identify compliant pathways to achieve commercial, educational, scientific, and operational objectives, including in ambiguous or evolving situations.
Escalate significant compliance concerns, emerging risks, investigations, and resource needs to the Chief Compliance Officer and appropriate business leaders.
Healthcare Compliance Program Implementation
Implement Marmon Medical Group policies, standards, and procedures at MicroAire and develop or update MicroAire-specific procedures where local operating processes are needed.
Guide and support controls related to interactions with HCPs and HCOs, including consulting arrangements, advisory boards, speaker programs, grants, sponsorships, fellowships, research support, medical education activities, meals, travel, lodging, and educational items.
Partner with Legal and business stakeholders to ensure HCP arrangements are supported by a documented legitimate business need, written agreement, fair market value determination, proof of performance, appropriate approvals, and accurate recordkeeping.
Support implementation and ongoing use of compliance systems and tools, including HCP engagement, grants/sponsorships, FMV, transparency reporting, training, policy management, and documentation platforms.
Advise on promotional, commercial, scientific, and medical education practices and help ensure appropriate review, documentation, and separation of commercial and non-promotional activities.
Risk Assessment, Work Planning & Monitoring
Conduct periodic compliance risk assessments for MicroAire, including interviews with leaders and key stakeholders, review of business activities, and analysis of relevant internal and external risk indicators.
Develop and execute an annual MicroAire compliance work plan aligned with Marmon Medical Group priorities and tailored to MicroAire’s specific risk profile.
Design and perform risk-based monitoring activities, such as field rides, review of HCP engagements, grants/sponsorships, advisory boards, trade shows, expense activity, and other high-risk processes.
Track action items, remediation plans, control enhancements, and workplan progress; report meaningful trends, issues, and program effectiveness indicators to the Chief Compliance Officer and MicroAire leadership.
Collaborate with Finance, Internal Audit, Quality/Regulatory, HR, Legal, and business owners to strengthen controls and address audit or monitoring findings.
Training, Communications & Culture
Develop and deliver targeted in-person and online training for MicroAire personnel, agents, independent contractors, distributors, and other relevant third parties.
Explain the “why” behind healthcare compliance requirements in a practical, business-relevant way that improves decision-making and supports a culture of integrity.
Create and deliver compliance communications, FAQs, reminders, and leadership talking points that reinforce expectations and make compliance approachable and workable.
Promote awareness of reporting channels, non-retaliation expectations, and speak-up/listen-up behaviors across MicroAire.
Chair or facilitate the MicroAire Compliance Committee in collaboration with the Chief Compliance Officer and business leadership.
Prepare committee agendas, materials, minutes, action tracking, and periodic program updates that support effective oversight and accountability.
Support compliance investigations, including hotline matters and other reported concerns, in coordination with the Chief Compliance Officer, Legal, HR, Finance, Quality/Regulatory, or other stakeholders as appropriate.
Document investigation activity, conclusions, corrective actions, and lessons learned in accordance with company processes and confidentiality expectations.
Partner with business owners to implement corrective and preventive actions that address root causes and reduce repeat issues.
Third-Party, International & Cross-Functional Support
Provide compliance guidance on third-party relationships, including distributors, agents, consultants, independent contractors, and other intermediaries; coordinate with Marmon Corporate and the Medical Group on diligence requirements.
Collaborate with the International Business Lead, Regulatory Affairs, and the Chief Compliance Officer as necessary on cross-regional activities, distributor-led programs, OUS promotional materials, and country-specific compliance questions.
Highlight compliance considerations in business development, product initiatives, customer programs, distributor activities, and other strategic projects involving MicroAire products or personnel.
Serve as a practical bridge between MicroAire’s day-to-day operations and Marmon Medical Group’s compliance standards, tools, and shared-service resources.
Required Qualifications
Bachelor’s degree required; advanced degrees such as JD, MBA, MPH, MHA, or other relevant graduate degree preferred.
7+ years of relevant healthcare compliance, legal, regulatory, audit, risk management, or equivalent experience in the medical device, life sciences, healthcare, or other highly regulated industry.
Demonstrated knowledge of laws, regulations, and industry standards affecting medical device companies, such as the US Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, FDA promotional and quality-related considerations, Sunshine Act/Open Payments, state disclosure laws, OIG guidance, and the AdvaMed Code of Ethics. Experience with international medical device markets preferred.
Experience advising commercial, marketing, medical education, scientific, clinical, R&D, regulatory, finance, HR, and/or legal stakeholders on healthcare compliance matters.
Experience implementing or improving compliance program elements such as policies and procedures, training and education, risk assessment, monitoring and auditing, reporting and investigations, corrective action, third-party diligence, and transparency reporting.
Ability to provide sound, practical advice in gray areas and to escalate issues appropriately.
Preferred Qualifications
Medical device experience is strongly preferred; aesthetics, surgical instruments, or medical education experience is a plus.
Experience supporting or collaborating with international business teams, distributors, or other third-party channels.
Certification in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), or similar credential preferred but not required.
Working Conditions / Other
Office, hybrid, and/or onsite work environment as determined by MicroAire and Marmon Medical Group business needs; regular in-person engagement with MicroAire teams is expected.
Domestic travel required as needed for MicroAire sites, sales meetings, trade shows, field rides, investigations, training, and stakeholder engagement; limited international travel may be required depending on business needs.
Ability to maintain confidentiality of employee, patient, customer, HCP, company, and investigation information.
This job description summarizes typical responsibilities and is not an exhaustive list of all possible duties. Responsibilities may change based on business, organizational, regulatory, and compliance program needs.
Pay Range:
144,000.00 - 216,000.00
We offer a comprehensive benefits package that may include medical, dental, vision, 401k matching, and more!
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.
Related keywords
Medical DeviceAnti-Kickback StatuteFalse Claims ActForeign Corrupt Practices ActFDASunshine ActOpen PaymentsOIG GuidanceAdvaMed Code of EthicsCHCCCEPHCP EngagementHCOFair Market ValueLMS PlatformsTransparency Reporting