Health Care Compliance Officer (m/f) Medical Devices in Norderstedt, Schleswig Holstein | DiversityInc Careers
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Health Care Compliance Officer (m/f) Medical Devices

Johnson & Johnson MEDICAL GmbH is a subsidiary of the Johnson & Johnson group acting worldwide with more than 129,000 employees. Since 1930, our responsibility towards our staff has been, and still is, an essential element of our Credo. High quality standards and an inspiring identification with our products and services distinguish us. Johnson & Johnson MEDICAL GmbH is a trendsetter in the area of medical technology. The Health Care Compliance Officer leads and drives the Health Care Compliance (HCC) program to ensure business practices and activities are in compliance with related J&J internal guidelines, local laws and regulations and anti corruption laws including the Foreign Corrupt Practices Act. The position holder serves as a strategic business partner for management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day to day business. This Director position reports to the Health Care Compliance Officer Medical Devices (MD) EMEA. This position is located in Germany, with assured reasonable presence at various MD/CMD offices, and oversees HCC Programs the MD & CMD business. This position will also be dotted line to the Country leader, MD and will assure appropriate connections with the business leaders of LifeScan and VisionCare and Surgical Vision. ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Partner with company executive leadership to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Conduct by:
    • Establishing & chairing the local Compliance Committee, the committee responsible for designing and implementing an effective compliance program and key decision making
    • Translating global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
    • Developing Country strategy & plan aligning with the businesses and J&J Office of Compliance; coordinate deployment.
    • Actively engage in the enterprise-wide Talent Management process for HCC
    • Assuring adequate representation in local business governance structures and establish discussion platforms to get general business buy-in and impact analysis
    • Acting as a consultant, and where appropriate, or required by the HCBI Guide assure review and approval for Health Care Professional (HCP)/Government Official (GO) oriented activities
    • Stimulating and contributing to innovative approaches towards HCPs and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews
    • Working with the J&J Office of Compliance, Government Affairs, Regulatory, Legal, and external organisations (primarily trade associations) to shape & influence the environment and industry codes of conduct
    • Providing and coordinating appropriate guidance, education, training, and regular communications on HCC to all covered employees, including Affiliate/Managing Director, Management Board, etc.)
    • Conducting self-assessment and risk assessment processes to detect process gaps & inconsistencies
    • Developing a testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate and engage Affiliate/ Board participation in roll out
    • Coordinating preparations for Corporate Internal Audits
    • Coordinate the establishment of the Management Action Plan, and guide the business partners to close gaps and implement corrective actions
    • Managing day-to-day allegations and investigations
    • Participating in and leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate
    • Providing metrics at Country level to J&J Office of Compliance
  • Additional responsibilities as follows:
    • Supervision of Compliance personnel Germany
    • Participation in the MD & CMD Local Committees
    • Lead/participate in Compliance Committee meetings as appropriate
    • Support the business leaders as strategic partner in compliance matters
    • Any additional projects as assigned by the HCC Officer MD CMD EMEA
  • Partnering with the Global/Regional Operations team to:
    • Develop and implement business specific policies and SOPs and customize global/regional policies & procedures and education & training materials to reflect local requirements
    • Implement IM systems that collect, audit, analyze, and report compliance information
    • Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
    • Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
    • Maintain employee certification and training attendance records
    • Execute Testing & Monitoring plans and programs
    • Ensure external reporting requirements are met per local regulations
    • Ensure internal reporting requirements are met per enterprise requirements and schedule
  • Interface with legal counsel regarding HCC requirements and interpretation
  • Interface with the global/regional HCC&P community to share approaches to HCC&P

  • BA/BS, advanced degree or equivalent preferred and a minimum of 12 years business experience. Prior experience in project management is required.
  • Supervising people experience is required.
  • Experience in Health Care Compliance is required.
  • Understands and masters the J&J Credo based culture.
  • Knowledge of laws, regulations and industry standards for UK/Ireland a plus.
  • Deals well with ambiguity and demonstrates strong organizational, process and interpersonal skills. Ability to work well between functions and across all levels of the business and effective negotiating skills are essential.
  • Ability to comprehend and interpret legal documents would be an advantage.
  • Proven success at people management and talent development.

Primary Location
Germany-Schleswig Holstein-Norderstedt
Johnson & Johnson Medical Products GmbH (7519)
Job Function
Health Care Compliance
Requisition ID