Compliance Specialist

Under the direction of General Counsel, the Compliance Specialist will ensure that the company complies with federal, state, local and industry regulations, and standards. The CS will stay abreast of all changes in tobacco and related development regulations in the US and abroad, to help guide process changes within our organization. The CS will contribute to regular review, updates, training and testing of existing compliance policies and processes to continue ensuring proactive risk management and expertise for Fumari as it grows globally.

Roles and Responsibilities

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  Manage the company’s compliance with state, federal, and international laws. Review, develop and edit SOPs to ensure they are consistent with corporate objectives and regulatory agency compliance requirements. Manage education and communication of company wide policies.
• File timely and accurate regulatory reports with governmental authorities for the company in compliance with all regulatory requirements. Maintain accuracy of multiple product lines. Coordinate with both internal and external stakeholders on queries related to reports submitted.
• Deliver and oversee internal required employee compliance training, maintain and schedule employee training logs. Responsible for representation during preparation of audits, in collaboration with other departments. Facilitate internal audits including a review of previous regulatory bodies, third party and internal audits to confirm and track implementation of proper corrective action or recommendations.
• Initiate and follow-through on Corrective and Preventative Action (CAPA) programs as required. Responsible for investigations of potential compliance issues in accordance with company policy. Manage key performance indicators (KPIs), tracking compliance, and risk management.
• Provide compliance reporting and metrics to management based on internal investigations and best practices. Qualify and develop relationships with external vendors to advance business partnerships are aligned to our regulatory process.
• Design and implement overall risk management process for the company including conducting risk assessments, creating policies and protocols to mitigate such risks, and perform continuous risk monitoring.
• Create and maintain various complex databases of information necessary for compliance purposes. Review and assess potential intellectual property violations and developing monitoring tools to prevent future violations.
• Work closely with the Legal department to ensure appropriate legal risk management.
• Assist with government affairs and legislation as it relates to the company.
• Work closely with legal department on FDA projects and pathways.
• Help to develop and monitor company product recall program and policies.

Qualifications and Education Requirements

Preferred Skills

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  Proven compliance experience within the tobacco, pharmaceutical, medical device, and/or biotechnology industry preferred
• Previous experience and/or familiarity with the legislative process preferred but not required
• Active participation in regulatory authority audits experience preferred
• Hookah experience always a plus!

What's in it for you?

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  Fixed and relaxed work environment
• Comprehensive benefits package including health, dental and vision upon hire!
• Employer paid Life Insurance
• Employer matched retirement plan
• Paid holidays
• Monthly luncheons
• And more...