Regulatory Compliance Specialist 5
Business Unit: Legal and Compliance
Requisition Number: 233278
Primary Location: United States-Pennsylvania-Malvern
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global med-tech company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
For more information, please visit:
The Healthineers Compliance Expert will report to the Head of Compliance North America and will protect business interests and ensure resolution/addressing of compliance issues. The Compliance Expert will help implement and support the Compliance strategies of Siemens Healthineers.
· Ensure conformance with applicable laws and regulations
· Conceptualizes, manages, leads and coordinates compliance processes and procedures.
· Conceptualizes, develops, conducts and directs the implementation of related training/training materials on compliance topics for the relevant functions.
- Ensure implementation, monitoring and auditing of the Siemens Compliance System
- Act as an trusted advisor to Management of various functions with respect to compliance matters
- Develops & ensures implementation of the compliance communication strategy to foster a values-based culture
- Evaluates the adequacy and effectiveness of internal risk management; observe risk trends for the industry and help implementing risk mitigation measures
- Proactively function as compliance representative toward external constituencies, further strengthening Siemens position as compliance benchmark.
- Assist and ensure conformance with Compliance related matters in M&A projects from the due diligence phase to final integration and/or divestment
- Direct involvement in the investigations, remedy, and disciplinary sanction of complaints and violations. Ensures any criminal proceedings or proceedings that may result in sanctions are handled in accordance with corporate interests, including complex assessment and forensic services.
- Demonstrated knowledge of legal, regulatory and political environments in the compliance areas
- Commitment to promoting Siemens’s mission and values
- Strong process management skills
- Strong leadership skills and value orientation
- Business results and customer orientation
- Experience in risk assessment and strategic approach to risk mitigation
- Proven ability to independently lead and execute all facets of challenging multi-disciplinary engagements with highest integrity and ethics
- Highly effective negotiation, communication, listening and drafting skills for interaction with senior managers and executive leadership within a global and matrixed organization
- Familiarity with commercial law, particularly within the healthcare environment
- Understanding of the regulatory environment, including FDA regulations, anti-kickback laws, fraud and abuse statutes, data protection and privacy laws applicable to medical device manufacturers
- Demonstrated skill in working collaboratively with multiple teams simultaneously and coordinating with multi-jurisdictional and multi-cultural transaction partners
- Excellent and detailed research and analytical skills
- Change management experience
Job Family Specific Responsibilities:
Ensures conformance with applicable laws and regulations and ensures risk awareness and mitigation measures to be implemented for global Siemens Healthineers.
Maintains advanced knowledge of legal and political developments in the compliance area and safeguards corporate interests in relevant legislative procedures. Prepares periodic compliance reporting to management and, as appropriate, to regulatory bodies.
Performs leading-edge areas of work for the professional field. Preempts potential problems and provides effective solutions in reaction to application of concepts, techniques, knowledge, or processes. Displays original thinking in applying principles, theories, and concepts on a wide range of problems.
BS/BA in related discipline or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Knowledge and Experience:
Demonstrates extensive knowledge in field of specialization or multiple disciplines to the successful completion of complex assignments. Successfully serves as point of authority and/or source of technical/scientific knowledge for area of expertise. Demonstrates comprehensive knowledge of organization’s business practices and issues faced and contributes to problem resolution of those issues. Typically 7 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above required.
Direction of Others
Develops team members through mentoring and coaching in complex subjects.
Key Working Relationship
Serves as key member of Head of Compliance North America and serves as advisor to top management and business partners on advanced technical matters.