Director, Compliance Investigations and Monitoring
Job Summary
The 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).
How you will make an impact:
Investigations & 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.
Regional 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 fieldworkincluding transaction testing documentation review and data samplingand 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.
Data 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.
Cross-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.
Other incidental duties and special projects as assigned by the Global Sr. Director Compliance Investigations & Monitoring
What you will need:
Bachelors Degree in or equivalent in Accounting/Finance or a related field and 12 years of experience in Law Accounting Law Accounting Finance Business Administration and in Health Care Compliance
Masters Degree or equivalent and 10 years of experience in Legal Internal Audit Finance and in Health Care Compliance
Other: Certified Compliance & Ethics Professional (CCEP) Certified Internal Auditor (CIA) Certified Fraud Examiner (CFE) or Certification in Healthcare Compliance (CHC)are preferred.
What else we look for:
Deep 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.
Demonstrated 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.
Proven 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.
Strong 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.
Effective 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.
Excellent verbal and written communication skills in English and Spanish (or Portuguese); ability to manage sensitive information with absolute confidentiality and to escalate emerging concerns with appropriate judgment and timeliness.
Proficiency in case management systems (e.g. NAVEX/EthicsPoint SAI360) data analytics tools and MS Office Suite.
Professional 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 roles regional scope.
Required Experience:
Director
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more