Corporate Compliance Manager (Medical Device) – RTP/Top $$

Our client, an RTP area medical device company in high growth mode, is actively recruiting for a very sharp, knowledgeable, and accomplished professional for key role overseeing broad range of Corporate Compliance functions.  

This is a critical role and Company will pay industry-leading wage including relocation support to attract and retain a top-notch candidate.

Company is launching in the US as well as several other countries. Operations are growing exponentially and managing corporate compliance is becoming increasingly complex and important.  Company seeks a seasoned Compliance professional who will help bring a best practices approach to this key function.

Key Things to Note:

• To date, most compliance functions have been managed by external consulting firms.  This is a newly created position intended to bring Compliance in-house.
• This is a broad-based role with early focus on Sunshine Act compliance.  Related expertise will be essential.
• This is a global company that sells in multiple markets.  Experience managing compliance in an international setting will be important.
• The company outsources many production functions.  Vendor contract compliance will also be involved and important.
• This position will begin as remote with the intention of moving in-house post-pandemic.  Seek candidate who will regularly commute to RTP office.

The Compliance Manager is responsible for the development, coordination, and implementation of the Company’s compliance program to foster a culture of high integrity and ensure there are adequate programs to manage healthcare compliance and ethics-related risks. 

Selected duties include:

• Develop, monitor, and report on the corporate compliance program and guide the Company toward continuous compliance with U.S. and International Healthcare Compliance laws and regulations.
• Work closely with all functions to ensure ethics and compliance objectives/initiatives coincide with strategic business initiatives in a compliant manner
• Develop and deliver company-wide ethics and compliance training for all employees and agents
• Analyze the company's compliance risk areas and develop risk mitigation strategies through a risk assessment process
• Oversee annual assessment of consulting needs and ensure contracts are in place prior to consulting services being received from customers/ potential customers i.e., Healthcare Professionals.
• Report on compliance activities and company risk profile to the Board of Directors
• Perform compliance investigations as needed including proposing corrective and preventative actions. Participate in cross-functional disciplinary committee as needed.
• Monitor external developments in compliance and proactively address in areas related to compliance education and training
• Develop an audit and monitoring program including performing audits as needed.

The Compliance Manager will oversee compliance matters affecting a broad range of functions and interface with a broad range of stakeholders.  In addition to demonstrating the requisite technical expertise involved in driving compliance in a publicly held, FDA-regulated setting, selected candidate will offer the demonstrated ability to build collaborative and productive relationships with involved departments, vendors and customers.  Further, as this is a growing/changing setting, the ability to develop, implement and maintain smart compliance policies will be critical.

Targeted candidate will offer a related degree (advanced degree desirable) and 5+ years of increasingly responsible compliance experience including 2+ years actively involved in compliance in the medical device or pharmaceutical industry. Sunshine Act exposure is essential.

Beyond that, we seek an achiever with a stand-out record of impact. 

Client is prepared to pay top dollar to attract and retain their candidate.  If interested and qualified, please forward Word resume for prompt consideration.