Compliance Manager or Senior Manager

Masimo Corp.

Irvine, CA

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Job Summary:

The Healthcare Compliance Manager or Senior Manager will assist in the implementation of the corporate compliance program and facilitate the accurate reporting of global healthcare provider (HCP) transparency reporting obligations.  The Compliance Manager will assist in the development and implementation of compliance training programs.

The successful candidate will have previous industry experience and be familiar with applicable laws, regulations, and industry standards pertaining to the medical device or pharmaceutical industry (Anti-kickback Statute, False Claims Act, Physicians Payment Sunshine Act, and Foreign Corrupt Practices Act, AdvaMed, MDMA).  

Duties & Responsibilities:

  • Provide compliance guidance to various departments and business units and help to resolve compliance matters under minimal supervision.
  • Assist with managing global transparency reporting obligations to comply with U.S. “Sunshine Act”, state transparency reporting requirements, and global HCP transparency reporting requirements.
  • Track and stay abreast of new or revised U.S. and international “Sunshine Act” reporting requirements.
  • Collect, consolidate, review, and monitor data and metrics from across the organization in order to identify emerging compliance trends or issues.
  • Develop compliance analytics methods, management reports, and perform analytics and monitor HCP spend data. Research and troubleshoot anomalies to identify and understand underlying business activities behind transactions.
  • Develop annual compliance training plans and coordinate training programs on company policies and various compliance topics, including anti-corruption, interactions with healthcare providers, conflicts of interest, and other areas.
  • Interact with other business units and departments, such as Sales, Marketing, Medical Affairs, Clinical, Legal, Finance, HR and Regulatory to provide guidance on compliance-related activities.
  • Support other compliance-related projects as required.

 

Minimum & Preferred Qualifications and Experience: 

Minimum Qualifications:

  • 6-8 years of experience in a compliance, legal, or internal audit function
  • Experience working in the medical devices, healthcare, pharmaceutical industry
  • Familiarity with relevant laws, regulations, industry guidance regarding medical device or pharmaceutical industry interactions with healthcare providers (Anti-kickback Statute, False Claims Act, Physicians Payment Sunshine Act, and Foreign Corrupt Practices Act, AdvaMed, MDMA).
  • Strong understanding of what it means to be a compliance and ethics professional with a good sense for practical solutions
  • Excellent communication and interpersonal skills
  • Identify and resolve problems in a timely manner, gather and analyze information skillfully
  • Excellent data analysis and reporting skills and ability to synthesize data into meaningful reports
  • Proficient in Excel; knowledge of proper pivot table analysis; competency in data validation and navigation
  • Excellent oral and written communication skills; ability to interact effectively with associates at all levels of the organization
  • Proactive, flexible, responsive and resourceful

Preferred Qualifications:

  • N/A

 

Education:

  • Bachelor’s degree in related field (Business, Finance, Accounting); Master’s degree is a plus
Physical requirements/Work Environment

 

This position primarily works in an office environment. It requires frequent sitting, standing and walking.  Daily use of a computer and other computing and digital devices is required.  May stand for extended periods when facilitating meetings or walking in the facilities.  Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.  Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.