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Company Name:
Approximate Salary:
Not Specified
Chicago, Illinois
Job Type:
Position type:
Full Time
Health Care
Health Care Law
Experience level:
5 - 7 Years
Education level:
Juris Doctor
2090 Dunwoody Club Drive #106

Global FDA and HCL Compliance Counsel

Our client, the HEALTHCARE DIVISION of a large company, is seeking to hire a FDA Regulatory and Healthcare Compliance Legal Counsel. The successful candidate will serve as the subject matter expert, program manager and strategic advisor on all global healthcare compliance laws and regulations including:

-medical device marketing authorizations


-promotion and quality operations

-US Anti-Kickback Statute and Sunshine Act

The hired individual will support the development and execution of strategies, policies and key initiatives; lead and assist in the design, implementation and ongoing maintenance of a global compliance program; monitor the external regulatory environment and identify and analyze legal risks and propose necessary actions and assist on audits when necessary.  In addition, this position will also include assisting with other compliance obligations regarding things such as grants,  sponsorships, pricing, etc., as well as fraud and abuse and transparency global laws.  There will also be some general healthcare support to various functions.

To be considered, must have 5 + years of Healthcare regulatory and compliance experience.  Must have FDA experience.  Preference for in-house experience, in addition to law firm experience.  In-house experience can be from either a medical device, bio-tech or pharma corporation.  Must possess a strong academic record along with excellent oral and written communication skills.

Healthcare is relatively new for this company but they are making a BIG splash in this space - big data analytics, clinical and health data cloud.  A very special role - one where a real difference will be made!

This position can also sit in New York, Boston or Raleigh.

For additional information and consideration, please contact:

Holly Davis @ hdavis@davissearch1.com 

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