Senior Compliance Manager EMEA

Merit Medical Systems, Inc.; Maastricht; On-site; EUR 70,000 - 90,000; Full time

Job summary

Merit Medical Systems, Inc. is seeking a Compliance Officer to lead its Compliance Program in the EMEA region. Responsibilities include managing compliance risk, overseeing training for employees and distributors, and ensuring adherence to healthcare regulations and laws such as GDPR and anti-corruption statutes. The ideal candidate should have a Bachelor's Degree in Business, seven years of experience in compliance within healthcare, and strong communication and organizational skills. Position based in Maastricht, Netherlands.

Qualifications

• Seven years of compliance, regulatory or quality experience in a healthcare organization.
• Strong understanding of FCPA, UK Bribery Act, and related regulations.

Responsibilities

• Lead Merit’s Compliance Program in the EMEA region.
• Assist in investigations of hotline complaints.
• Oversee compliance training for employees and distributors.
• Monitor health care laws and regulations.
• Develop onboarding due diligence process for international distributors.

Skills

Verbal and written communication skills

Organizational skills

Presentation skills

Understanding of EU Healthcare regulations

Expertise in GDPR regulations

Knowledge of anti-corruption laws

Education

Bachelor's Degree in Business or related field

Job description

Summary of Duties

To assist the Chief Compliance Officer in overseeing the Corporate Compliance Program and 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.