POSITION SUMMARY:

We are seeking a strategic and experienced Compliance Director to oversee and manage 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 leadership, risk management acumen, 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:

• Develop, implement, and oversee the regional compliance strategy in alignment with global corporate policies and regulatory requirements
• Serve as a subject matter expert on healthcare compliance (including Anti-Kickback Statute, False Claims Act, FCPA, AdvaMed Code, and local equivalents in LATAM and Canada
• Lead the risk assessment and mitigation process for the Americas, identifying and addressing 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
• Represent the region in global compliance meetings and projects, acting as the voice of the Americas in shaping company-wide compliance initiatives.
• Keep abreast of regulatory changes and enforcement trends affecting the medical device industry.
• Assisting in drafting, reviewing, revising, and implementing compliance policies and procedures globally
• Providing recommendations for and supporting the execution of the training and communication plan
• Participate in conducting risk assessments to detect process deficiencies, and revise and recommend changes to the Work Plan to address the identified deficiencies
• Conduct annual risk assessments and recommend changes to the Annual Work Plan accordingly
• Other duties as assigned by the Chief Compliance Officer

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance or remote work as agreed to with the Chief Compliance Officer
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor of Arts or Bachelor of Science
• Minimum of 10 years of healthcare industry experience, with at least five years’ experience in pharmaceutical or medical device compliance management
• Absolute commitment to integrity and professional ethics
• Expertise in anti-kickback, anti-bribery, anti-corruption laws, and privacy laws applicable to the Americas as well as FDA on-label promotional requirements.
• Strong knowledge of the AdvaMed Code
• Strong organizational, interpersonal, analytical and communication skills
• Proven track record of both strategic and tactical 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 25%)

PREFERRED QUALIFICATIONS:

• Prior experience as Compliance Officer for a business unit or operational region of a medical device, biotech or pharmaceutical company
• JD, MBA, or other professional degree preferred

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
• Up to 25% travel may be required

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