EMEA Compliance Leader: Strategy, Risk & Privacy

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

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.