JOB SUMMARY – To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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.
PHYSICAL/WORK REQUIREMENTS
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