Compliance Specialist, EMEA
Position Overview
Support the EMEA Legal & Compliance Management with overseeing compliance processes and related activities across the region, such as internal controls, performing monitoring testing, maintaining databases and structuring data collection. Participate in and support the development and implementation of the formal corporate compliance program; support the 231 Italian model implementation and sustainability as applicable. Job duties:
- Actively support the development and deployment of compliance tools.
- Assist in compliance program implementation and actively interact with various corporate functions.
- Provide first level of analysis and advice on compliance matters.
- Orient EMEA associates on procedures and develop guidance and checklist to support associate compliance with the company’s requirements and boost a working environment where decisions are driven by integrity.
- Escalate issues to Legal and Compliance Management – EMEA as appropriate.
- Build specific database for data reporting and management.
- Help develop and expand the Compliance risk-based monitoring program.
- Coordinate data collection.
- Perform testing and monitoring (T&M) and relevant reporting and analytics in accordance with internal program and timelines. Prepare follow-up communications and corrective actions.
- Assist in the management of EMEA compliance programs with respect to healthcare related compliance statutes and codes of conduct, including anti-bribery and transparency compliance, such as Model 231 in Italy, as required.
- Assist with monitoring and testing programs on HCP engagement process, external funding, third-party management programs, and other processes identified as high-risk business interactions, as assigned.
- Coordinate with other compliance professional teams across the organization to align monitoring and testing and leverage expertise and lessons learned.
- Support / participate in “Transparency” related duties (coordination, data collection, publication) aligned with local regulations, ensuring effective reporting.
- Work on special projects as needed.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Compliance certificate or relevant experience in regional compliance.
- Minimum four (4) years of experience in administrative support or compliance.
- Medical device, pharmaceutical, or other healthcare-related experience required.
- Excellent written and verbal communication and interpersonal skills.
- Well-organized and autonomous in the organization of duties assigned.
- Demonstrated ability to quickly establish trust and rapport with other Associates at all levels.
- Working knowledge of or familiarity with compliance statutes and laws, both domestic and international.
- Familiarity with third-party management, healthcare environment, and transparency framework; familiarity with Italian 231 model (for incumbents in Italy only).
- Good responsiveness to priorities.
- English language proficiency (business nomenclature).
- Proactive and self-motivated.
- Strong organizational/time management skills.
- High degree of accuracy and attention to detail.
- Proficient computer skills such as competency in presentation, word processing, and spreadsheet software, including MS Word, Excel, Outlook, and Teams.
- Other significant educational or work experience related to the position.
- Experience in compliance in the medical device field.
- Ability to work independently and as part of a team.
- Knowledge of laws (e.g., Anti-Kickback, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, etc.), regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities preferred.