Balt · 5 hours ago
Director of Compliance
United States
Full-time
Remote
Director/Executive
$200K/yr - $250K/yr
10+ years expBalt is a rapidly growing pioneer in the medical device industry, dedicated to improving the lives of patients. The Director of Compliance will lead the global compliance program, ensuring adherence to laws and ethical standards while overseeing various compliance areas such as anti-bribery and data privacy.
Health CareManufacturingMedical Device
Responsibilities
Develop, implement, and oversee a robust global compliance framework aligned with industry best practices and applicable laws (e.g., FCPA, Anti-Kickback Statute, UK Bribery Act, EU MDR, Sunshine Act, GDPR, global sanctions lists, etc.)
Lead risk assessments to identify and prioritize compliance risks across markets and business units
Establish and maintain global compliance policies, procedures, systems, and training programs to promote an ethical culture and ensure consistency across regions
Design and oversee compliance monitoring and auditing programs to assess program effectiveness and identify improvement opportunities
Track and report key compliance metrics and program updates to senior management, the Audit Committee, and/or the Board of Directors
Ensure timely investigation, remediation, and documentation of potential compliance violations, including reports submitted through the whistleblowing hotline
Develop and deliver global compliance training programs tailored to various employee levels and functions
Foster a strong 'tone from the top' and promote a culture of integrity, transparency, and accountability
Partner with HR, Finance, Legal, and Communications to reinforce compliance values throughout the organization
Serve as a trusted advisor to senior executives and regional leadership teams on compliance matters related to commercial operations, clinical research, and product distribution
Provide compliance guidance for interactions with healthcare professionals (HCPs), distributors, and government officials
Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Legal teams to ensure alignment with medical device laws and ethical marketing requirements
Oversee due diligence and monitoring processes for distributors, vendors/suppliers, agents, and consultants
Implement consistent third-party compliance standards globally
Oversee investigations of reported compliance concerns; ensure proper escalation, root-cause analysis, and corrective actions
Manage whistleblowing hotline processes and ensure reporting mechanisms are effective and confidential
Qualification
Required
Advanced degree in Law, Business, or related field (J.D. preferred)
10+ years of compliance or legal experience, with at least 5 years in a leadership role within the life sciences industry (medical device experience strongly preferred)
Strong knowledge of healthcare compliance laws, anti-corruption regulations, data privacy laws, and industry codes (e.g., MedTech Europe, AdvaMed)
Experience managing global teams and implementing cross-border compliance initiatives
Strategic thinker with the ability to translate complex legal requirements into practical business processes
Strong communication and presentation skills, including experience briefing senior executives or boards
Proven ability to influence and collaborate across functional and cultural boundaries
High integrity, sound judgment, and commitment to ethical leadership
Fluent in English; proficiency in French or other languages a plus
Company
Balt
Balt is specialist manufacturer of 'Interventional Neuro Radiology’ (‘INR’) devices used to treat strokes and aneurysms
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$370.32M2024-12-20Debt Financing· $370.32M
2015-09-25Private Equity
2015-09-25Acquired
Leadership Team
Pascal Girin
CEO
Emeric Domergue
Deputy CFO
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