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Merit Medical System

Senior Compliance Manager - Western Europe
ReadingPermanentHybridFull-TimeLead

Posted 1 month ago

Description

About Merit Medical
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Summary of Duties
To assist the Chief Compliance Officer in overseeing the Corporate Compliance Program and in ensuring the Board of Directors, management, employees, and distributors are in compliance with the rules and regulations of regulatory agencies, that company policies and procedures are being followed, and that behaviour in the organization meets Merit’s Global Compliance Policy and Merit’s Global Anti-Corruption Policy.

Duties & Responsibilities
  • Leads Merit’s Compliance Program in the Europe, Middle East and Africa (EMEA) geographical region, including the supervision of its regional compliance team.
  • Participates in and provides compliance support for projects and initiatives with moderate to high risk to identify, assess and mitigate compliance risk in business activities.
  • Develops and implements testing methodologies to evaluate the effectiveness of compliance policies, procedures and processes including auditing and monitoring of compliance risk areas.
  • Assists and coordinates in the investigations of hotline complaints.
  • Identifies, documents and reports findings and issues to the Chief Compliance Officer.
  • Creates corrective action plans, communicates and manages the change to ensure compliance with federal, state, agency, legal, regulatory and internal requirements.
  • Creates and enhances regional policies and procedures to address compliance risks and continually improve Merit’s compliance Program.
  • Oversees compliance training for Merit employees, distributors and other third parties.
  • Assists in the development and maintenance of centralized tracking tools for engaging with and supervising consultants.
  • Monitors health care laws and regulations, including educating employees and establishing systems for compliance.
  • Assists in the tracking and reporting of transfers of value to health care providers to ensure compliance with Sunshine laws and regulations in European Union countries and other countries.
  • Conducts Fair Market Value (FMV) calculations for Health Care Professionals when retained as consultants and prepares Consulting Agreements in coordination with Legal.
  • Develops and maintains onboarding due diligence process for international distributors.
  • Assists in enhancing Merit’s privacy compliance program in accordance with the GDPR and other global privacy laws and regulations.
  • Maintains the ethical and professional standards of the compliance profession in the business environment.
  • Performs a variety of other related duties, as required.

Summary of Minimum Qualifications
  • Education and/or experience equivalent to a Bachelor's Degree in Business, Business Law, or related field.
  • Seven years of compliance, regulatory or quality experience in a healthcare organization.
  • Excellent verbal and written communication skills.
  • Excellent organizational and managerial skills.
  • Strong presentation skills.
  • Understanding of EU Healthcare regulations and pertinent laws governing medical products in manufacturing and marketing.
  • Working knowledge or expertise in the European Union’s GDPR regulations, including best practices in the privacy area.
  • Understanding of FCPA, UK Bribery Act, the Anti-Kickback Statute, the False Claims Act, and other anti-corruption laws and regulations.
  • Familiarity with operational, financial, quality assurance and human resources procedures and regulations.

Merit Medical Systems, Inc. is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees.
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Merit Medical System logo

Merit Medical System

Leading manufacturer of proprietary medical devices for interventional procedures worldwide

South JordanMedical Devices1000+
Merit Medical System logo

Merit Medical System

Medical Devices

Join a global medical device manufacturer with consistent 20% annual growth, where your work directly enables life-saving interventional procedures. Merit values technical innovation and clinical impact in a performance-driven culture.