Director, Compliance Investigations and Monitoring
hace 9 días
Valencia
ppThe Director, Compliance Investigations Monitoring is responsible for independently conducting complex compliance investigations, executing and coordinating risk-based compliance monitoring activities across assigned regions, and partnering closely with regional compliance teams and business stakeholders to ensure that investigation and monitoring outcomes are translated into effective, locally relevant remediation or enhancements. The role requires strong investigative judgment, a solid working knowledge of healthcare and life sciences regulatory frameworks, and the ability to operate with meaningful autonomy under the strategic direction of the Global Senior Director, Compliance Investigations Monitoring. This position plays an important role in cultivating a culture of psychological safety, integrity, and ethical business conduct consistent with the Global Business Practice Standards (the "Titanium Book"). /p h3How you will make an impact /h3 ul liInvestigations Root Cause Analysis: Independently conduct complex compliance investigations from intake through final disposition, including evidence gathering and preservation, witness interviews, data analysis, root cause determination, and the preparation of well-documented investigation reports with findings, conclusions, and actionable recommendations for corrective and preventive measures. /li liRegional Compliance Monitoring Remediation: Develop and execute risk-based compliance monitoring plans for the EMEACLA region and other assigned areas, in close partnership with the Regional Compliance Lead and local business teams. Conduct monitoring fieldwork—including transaction testing, documentation review, and data sampling—and prepare detailed monitoring reports with findings, exceptions, and remediation recommendations. Track remediation commitments to completion, ensuring that corrective actions are effectively implemented and that monitoring outcomes are integrated into broader regional compliance program activities. /li liData Analysis, Reporting Intelligence: Analyze investigation findings and monitoring results to identify trends, risk-based themes, and areas of emerging concern. Prepare clear, well-structured reports, metrics, and presentations that translate investigative and monitoring data into actionable intelligence for the Global Senior Director, Compliance Investigations Monitoring, the EMEACLA Regional Compliance Lead, and other relevant stakeholders. Propose and drive AI-powered improvement opportunities to Edwards Risk and Monitoring program. /li liCross‑Functional Collaboration, Stakeholder Engagement Continuous Improvement: Partner effectively with regional compliance colleagues and cross‑functional stakeholders, including Legal, Human Resources, Employee Relations, Internal Audit, Global Security, Quality Assurance, and Privacy, to ensure well‑coordinated investigation and monitoring processes, clear escalation pathways, and the seamless integration of outcomes into regional risk mitigation activities. Serve as a knowledgeable resource to team colleagues, contributing to training and awareness initiatives on the Speak Up program, non‑retaliation principles, and investigation‑related topics. /li liOther incidental duties and special projects as assigned by the Global Sr. Director, Compliance Investigations Monitoring. /li /ul h3What you will need /h3 pBachelor's Degree in or equivalent in Accounting/Finance or a related field and 12 years of experience in Law, Accounting, Finance, Business Administration and in Health Care Compliance. /p pMaster's Degree or equivalent and 10 years of experience in Legal, Internal Audit, Finance, and in Health Care Compliance. /p pOther: Certified Compliance Ethics Professional (CCEP), Certified Internal Auditor (CIA), Certified Fraud Examiner (CFE), or Certification in Healthcare Compliance (CHC) are preferred. /p h3What else we look for /h3 ul liDeep knowledge of the medical device and life sciences regulatory landscape, including FDA enforcement frameworks, the Anti‑Kickback Statute, the False Claims Act, the FCPA, the UK Bribery Act, EU Whistleblower Directive transpositions, and industry codes of conduct (AdvaMed, MedTech Europe). Solid working knowledge of specialized compliance domains such as anti‑bribery and corruption (ABC), data privacy (GDPR, CCPA), conflicts of interest, and third‑party risk management. /li liDemonstrated ability to independently conduct thorough, impartial, and well‑documented investigations across all phases of the lifecycle. Sound judgment in navigating complex factual scenarios, assessing evidentiary sufficiency, and producing high‑quality investigation work product. Meticulous attention to detail in evidence handling, case documentation, and report preparation. /li liProven ability to design, execute, and follow through on risk‑based compliance monitoring activities, including fieldwork planning, exception analysis, and remediation tracking. Comfortable operating in a regional context and adapting monitoring approaches to reflect local regulatory requirements and business practices. /li liStrong data interpretation skills with the ability to extract trends, risk‑based themes, and actionable insights from investigation and monitoring data, and to communicate findings clearly in reports and presentations for diverse audiences. Interest in leveraging technology to enhance analytical capabilities. /li liEffective interpersonal and relationship‑management skills with a demonstrated ability to build rapport and productive partnerships with regional compliance leads, business teams, and cross‑functional stakeholders across Legal, HR, Global Security, Quality, and Privacy. Comfortable working across cultures, languages, and time zones. /li liExcellent verbal and written communication skills in English and Spanish (or Portuguese); ability to manage sensitive information with absolute confidentiality and to elevate emerging concerns with appropriate judgment and timeliness. /li liProficiency in case management systems (e.g., NAVEX/EthicsPoint, SAI360), data analytics tools, and MS Office Suite. /li liProfessional fluency in English and Spanish is required. Additional proficiency in Portuguese, French, or other European languages is strongly preferred and considered a significant advantage given the role’s regional scope. /li /ul /p #J-18808-Ljbffr
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