Compliance Program Manager to design and build global compliance program for Medtronic Diabetes. Leading compliance initiatives, aligning programs with public company standards and shareholder expectations.
Responsibilities
Serve as a critical member of the compliance team and support the development and implementation of the global compliance program to effectively mitigate compliance risks associated with the sale of diabetes products to HCP interactions and directly to patients.
Provide strategic oversight and direction for major elements of the global compliance program, such as the policy, training and/or auditing and monitoring programs and support other elements of the compliance program, as needed.
Lead initiatives that enhance global program maturity, ensuring alignment with regulatory requirements, industry best practices, and evolving business models.
Support the hotline and investigation program and conduct certain investigations.
Influence long-term compliance strategy through participation in the risk assessment process and the development of the compliance strategic workplan.
Advise the business on matters involving HCP Interactions and manage HCP interactions compliance-related reviews and processes, including transparency reporting.
Oversee high-impact compliance initiatives and facilitate change management, including milestone tracking, stakeholder engagement, communication planning, stakeholder engagement, training deployment, and executive reporting.
Guide complex compliance reviews, approvals, and risk-based decision-making.
Develop actionable metrics and leverage insights to identify trends, emerging risks, and opportunities to elevate program effectiveness.
Drive operational efficiency by optimizing workflows, identifying bottlenecks, and simplifying processes while effectively managing risk.
Lead projects that modernize compliance operations, including technology enablement, automation, and the adoption of artificial intelligence to streamline monitoring, approvals, and risk management activities.
Requirements
Bachelor's degree and 7 years of relevant experience
Or, advanced degree and 5 years of relevant experience
Juris Doctor (JD) degree
7 years of experience in senior compliance roles, ideally within a publicly traded medical device, biotech, or pharmaceutical company.
Deep knowledge of medical device regulatory environments (e.g., AKS, FCA, Transparency laws) and the DOJ and OIG compliance program guidance documents.
Familiarity with Anti-Bribery, anti-corruption, anti-trust and competition laws.
Experience with compliance-related technologies (e.g., third-party screening, transparency and Sunshine Act reporting platforms, HCP interaction platforms, etc.) and other workflow and automation technologies.
Project management skills and familiarity with operational efficiencies or continuous improvement methodologies (e.g. Lean, Six Sigma)
Experience managing compliance in a multinational environment.
Proven leadership and a track record of building high performing teams.
Excellent interpersonal, communication, and presentation skills.
Demonstrated ability to work with senior leadership and influence organizational culture.
Master’s in Law, MBA or equivalent advanced legal degree.
Certifications such as CCEP, CIPP, or CHC.
Experience in a direct-to-consumer business, CMS billing and reimbursement, and/or have worked for HIPAA covered entity.
Prior experience supporting a company through IPO, acquisition, or other major corporate event.
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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