Senior Compliance Manager EMEA
Core
Leads the Corporate Compliance Program for the EMEA region, ensuring adherence to regulatory agencies, company policies, and anti-corruption rules for a medical device manufacturer.
Role type
Senior Compliance Manager (EMEA)
Builds
Compliance program infrastructure, risk mitigation strategies, and training systems for a global medical device company.
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Compliance program management, risk assessment and mitigation, audit and monitoring, investigation coordination, policy development, corrective action planning, GDPR compliance, anti-corruption law knowledge (FCPA, UK Bribery Act, Anti-Kickback Statute), Fair Market Value calculations, distributor due diligence, healthcare law monitoring
Preferred skills
Experience in healthcare organizations, knowledge of EU healthcare regulations, privacy compliance expertise, change management
Technologies
Centralized tracking tools, Consulting Agreements
Responsibilities
Supervise regional compliance team, assess and mitigate compliance risks in business activities, develop and implement testing methodologies for compliance policies, coordinate investigations of hotline complaints, create corrective action plans, oversee compliance training for employees and third parties, monitor health care laws and regulations, track and report transfers of value to health care providers, perform Fair Market Value calculations for consultants, maintain onboarding due diligence process for international distributors, enhance privacy compliance program per GDPR
Seniority
Senior, hands-on IC