Senior Compliance Manager EMEA

Merit Medical Systems; Maastricht; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salaries

Learning opportunities

Internships

Job summary

Merit Maastricht, the European Headquarters for Merit Medical Systems, seeks a seasoned Compliance leader to oversee the Corporate Compliance Program across the EMEA region. You will guide regional teams, ensure adherence to healthcare regulations, and manage investigations and training.

The role requires extensive experience in EU regulatory affairs, GDPR, and anti-corruption laws, with a strategic focus on policy improvement and stakeholder collaboration.

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 laws governing medical products.
• Working knowledge of GDPR regulations.
• Understanding of FCPA, UK Bribery Act, Anti-Kickback Statute and False Claims Act.
• Familiarity with operational, financial, QA and HR procedures.

Responsibilities

• Leads Merit’s Compliance Program in Europe, Middle East and Africa (EMEA) region, supervising regional compliance team.
• Provides compliance support for projects with moderate to high risk to identify, assess and mitigate risk.
• Develops testing methodologies to evaluate compliance policies and audits.
• Assists investigations of hotline complaints.
• Documents findings and reports to Chief Compliance Officer.
• Creates corrective action plans and manages changes to ensure regulatory compliance.
• Enhances regional policies and procedures to address compliance risks.
• Oversees compliance training for employees, distributors and third parties.
• Maintains centralized tracking tools for engaging with consultants.
• Monitors healthcare laws and regulations; educates employees and implements systems for compliance.
• Tracks and reports transfers of value to healthcare providers to ensure Sunshine laws compliance in EU and other countries.
• Performs FMV calculations for Health Care Professionals when retained as consultants; coordinates Consulting Agreements with Legal.
• Develops onboarding due diligence for international distributors.
• Enhances Merit’s privacy compliance program per GDPR and global privacy laws.
• Maintains ethical and professional standards in compliance.

Skills

Verbal communication

Written communication

Presentation skills

EU healthcare regs

GDPR knowledge

Anti-corruption laws

Education

Bachelor’s degree

Job description

Why Merit?

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.

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with an international sales force and clinical support team totalling in excess of 500 individuals.

Merit employs approximately 6,300 people worldwide. Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses.

More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture.

Diversity & Inclusion

Diversity & Inclusion is evident here with a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.

Founded in 1987

Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.

Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals.

Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER.

Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.

Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.