Angio

The Compliance Manager is responsible for implementing and leading the Company’s Compliance program. This position will be responsible for drafting and maintaining compliance policies that reflect the seven elements of an effective compliance program, training employees, interpreting legislation and regulatory trends, and providing guidance on compliance issues in the medical device industry.

Essential Duties and Responsibilities

• Partner across the company to construct appropriate risk-based monitoring, investigate compliance breaches, coordinate compliance activities, and work with various departments to enhance internal controls and business processes, ensuring the company meets its business goals in a compliant manner
• Maintain a current working knowledge of various laws, regulations and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG rules and regulation, AdvaMed guidelines, state marketing compliance laws and anti-bribery laws.
• Serve as the company’s primary compliance advisor to the Executive Leadership Team and Board of Directors
• Ensure compliance with the Sunshine Act reporting requirements and related transparency laws and regulations of other jurisdictions
• Lead enterprise-wide compliance risk assessments and establish mitigation plans
• Design monitoring and auditing processes to proactively identify and address compliance gaps
• Investigate potential compliance violations and manage remediation, corrective actions and reporting obligations
• May perform other duties as assigned

Education and Experience

• Bachelor’s Level of Degree. J.D preferred by not required
• 5 years of demonstrated experience in healthcare compliance
• Healthcare Compliance Certifications Preferred
• Any preferred education, experience or certifications: Experience working in a law firm, medical device or pharmaceutical company

Skills/Knowledge

• Strong working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program for a medical device company, including federal and state government price reporting laws, fraud and abuse and anti-kickback statues, OIG and AdvaMed guidelines, state marketing compliance laws, and anti-bribery laws
• Ability to manage and implement change effectively
• Proven leadership skills in managing complex processes
• Demonstrated knowledge of legal, regulatory and political environments in compliance areas
• Ability to build and manage relationships with business partners and colleagues
• Exceptional communication and presentation skills to convey complex legal and compliance topics in plain English in a practical manner
• Ability to thrive in a fast-paced, innovative environment with multiple priorities
• Highly self-motivated with the ability to gain trust and credibility quickly
• Strong team player with a customer and solution-oriented approach

• Proficient in the following computer software applications: Microsoft Office
• Exceptional interpersonal skills.
• Strong organizational skills.
• Ability to read and interpret documents such as safety rules, operating and maintenance. instructions, and procedure manuals. Ability to write routine reports and correspondence.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
• Exposure to standard office environment
• Ability to frequently lift and/or move up to 15lbs
• Ability to occasionally lift and/or move up to 50lbs
• Ability to regularly sit or stand for extended periods of time

• This position requires some travel up to 20% of the time