Director, Health Care Compliance Officer

Role Overview

• Set strategic direction, provide oversight, lead compliance efforts, ensure effective risk management and drive operational excellence for MedTech business unit(s)
• Serve as an internal compliance expert to senior leaders and key stakeholders, exercising judgment to mitigate business risk and manage resource allocation for business initiatives and enterprise projects
• Provide strategic guidance and compliance support for Shockwave Medical (Circulatory Restoration)
• Oversight and accountability for Shockwave’s integration into Johnson & Johnson compliance program
• Provide HCC oversight for business activities based on risk profiles
• Partner with colleagues to ensure compliance with HCC laws, regulations and industry standards related to health care products and services, interactions with health care professionals (HCPs) and/or government officials (GOs)
• Collaborate with business partners in the development and review of commercial and medical strategies, business plans, new business models, HCP/GO engagements, and company material to facilitate compliant growth
• Serve as a member of business leadership team(s) to represent HCC and provide input during strategy discussions and business planning
• Provide regular updates to business leadership and collaborate with stakeholders to effectively anticipate, prevent, and detect issues and correct violations of laws, regulations, or company policies
• Perform risk assessment, root cause analysis, risk mitigation planning and execution, and regular risk reviews to ensure compliance program effectiveness
• Foster a culture of accountability at all levels of the organization with a focus on credo-based decision making, integrity and operational excellence
• Partner with business partners and HCC colleagues to ensure governmental reporting obligations are met
• Identify potential compliance risks and issues associated with business activities and ensure involvement of appropriate individuals within HCC, Regulatory Affairs, Government Contracting & Compliance, Legal and other functions to provide appropriate guidance, risk mitigation and assurance of mechanisms in place for identifying and appropriately disciplining instances of non-compliance while ensuring consistency in the application of disciplinary action
• Identify and collaborate on compliance by design activities to integrate compliance-related requirements and controls into business processes and systems
• Work with industry associations and other external organizations to influence/develop industry policies and standards in close partnership with HCC Sector Lead
• Sponsor, lead and engage in tasks and project initiatives to advance Health Care Compliance and/or business-related goals

Requirements

• Bachelor’s degree is required
• Master’s degree in related field or other advanced degree preferred
• 10+ years of business-related experience required
• 5+ years of experience in HCC or related compliance/risk management function (e.g., Legal, Regulatory, Quality, Finance)
• 2+ years of People Management experience with strong track record of people management with ability to lead and develop team
• Knowledge of relevant laws, policies, standards, financial or auditing practices and company business and policies
• Knowledge about industry associations, their modus operandi and related policies is a plus
• Experience in the development and/or implementation of a compliance program and risk management solutions in accordance with an organization's risk profile
• Excellent verbal and written communication skills
• Ability to advise senior leaders and stakeholders on business initiatives or complex issues
• Strong collaboration with demonstrated evidence of maintaining relationships and partnerships with peers and business partners and ability to influence across all levels of the business
• Broad business experience with working knowledge of commercial sales and marketing practices and medical affairs strategies for healthcare products and services
• Ability to analyze data and trends, and communicate complex information to all levels of the company
• Engaging and personable demeanor; self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness, the ability to lead projects, and the ability to work through ambiguity and prioritize and execute on multiple and frequently changing priorities
• Experience working in a matrix environment to deliver solutions which drive compliant growth
• Experience working with the governmental regulatory bodies and managing HCC company policies preferred
• Experience working as an HCC or GCC Officer preferred
• Current Certified Compliance & Ethics Professional (CCEP®) and/or Certification in Healthcare Compliance (CHC®) status preferred

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year