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Years of Experience
Date Last Verified
Compliance Analyst The candidate will be responsible for oversight of NeoTract’s compliance program. Will provide expertise on compliance matters that support organizational objectives and mitigate risk to ensure business practices are conducted in accordance with company policies and other relevant requirements. Review and continuously improve the Company’s compliance program to ensure adherence with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act, the Foreign Corrupt Practices Act, and HIPAA. Will lead cross-functional business and governance projects, including defining, implementing, and analyzing processes and procedures that support the Company’s business objectives. Regularly communicate with management on the state of the compliance program and partner with stakeholders to develop strategies that manage compliance risks. Provide advice and training to team members and relevant stakeholders on the compliance program. Direct efforts to identify and assess compliance-related risks, including risk assessment, implementation of effective policies and procedures, training and education, and monitoring. Provide guidance to the Marketing and Sales teams. Perform audits of various elements of the compliance program. Stay current on applicable laws, regulations, and practices; and keep senior management apprised of current developments.
Qualification and Experience
The candidate should have Bachelor’s degree or equivalent practical experience. JD degree or advanced degree is preferred. Must have 5+ years of compliance, legal, or regulatory affairs experience in the medical device or life sciences industry. Experience analyzing and implementing compliance programs, and designing and implementing processes/controls is essential. Experience engaging with and crafting communications is essential. Familiarity/background in system implementations (CRM, accounting, process workflows, etc) is essential. Must have excellent quantitative, editorial and presentation skills; innovative, organized, thorough, and detail-oriented. Must have excellent communication skills, experience analyzing and implementing compliance processes.
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