POSITION SUMMARY:

We are seeking a Senior Compliance Manager, Americas to manage and execute the compliance program across the Americas region (North, Central, and South America). This individual will ensure adherence to applicable healthcare, anti-corruption, regulatory, and data privacy laws. The role requires strong compliance and risk management skills, and the ability to partner cross-functionally with commercial, legal, regulatory, and operational teams. This is an individual contributor role with the opportunity for growth.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Manage the implementation and execution of the regional compliance strategy in alignment with global corporate policies and regulatory requirements
• Provide subject matter expertise and guidance on healthcare compliance (including Anti-Kickback Statute, False Claims Act, FCPA, AdvaMed Code, and local equivalents in LATAM and Canada
• Support and execute the risk assessment and mitigation process for the Americas, helping to identify and address emerging compliance risks in the Americas region.
• Involvement with the third-party due diligence process, including distributors, consultants, and vendors.
• Partner with legal, and HR teams to investigate and remediate compliance incidents.
• Support monitoring and auditing programs and remediate identified issues.
• Collaborate with commercial leaders to ensure compliant business practices, particularly around interactions with healthcare professionals (HCPs) and referral sources.
• Review HCP engagement needs assessments, participate in research grants and educational grants review committees
• Participate in global compliance meetings and projects, providing regional input and helping to execute company-wide compliance initiatives.
• Keep abreast of regulatory changes and enforcement trends affecting the medical device industry.
• Assist in drafting, reviewing, revising, and implementing compliance policies and procedures globally
• Manage the execution of the training and communication plan, providing recommendations as appropriate
• Participate in conducting risk assessments to detect process deficiencies, and revise and recommend changes to the Work Plan to address the identified deficiencies
• Provide input on annual risk assessments and recommend changes to the Annual Work Plan accordingly
• Other duties as assigned by the Chief Legal Officer

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance or remote work as agreed to with the Chief Legal Officer
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others and contribute to overall team performance
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor of Arts or Bachelor of Science
• Minimum of seven years of healthcare industry experience, with at least three years’ experience in pharmaceutical or medical device compliance or quality management
• Absolute commitment to integrity and professional ethics
• Understanding of laws and industry standards governing medical device company interactions with healthcare professionals
• Strong organizational, interpersonal, analytical and communication skills
• Strong track record of tactical execution and operational management capabilities, demonstrating the ability to:

• • Innovate and execute in a complex business environment
  • Foster relationships and influence business decisions and business partners, both throughout the company and external parties
  • Combine regional orientation with global goals and objectives
  • Manage complex, cross functional or global projects to conclusion

• Committed team player while taking initiative to get results with minimal supervision
• Ability to travel regionally (up to 50%)

PREFERRED QUALIFICATIONS:

• Prior experience as Compliance Officer for a business unit or operational region of a medical device, biotech or pharmaceutical company

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as required
• Ability to occasionally bend and push/pull
• Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds
• Ability to pass pre-employment drug screen and background check