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Chief Compliance Officer / Corporate Counsel
Refer job# ZTIY139898
 
Chief Compliance Officer / Corporate Counsel The candidate will ensure organizational compliance with laws, industry requirements and Company policies to build a culture of compliance that is woven into the fabric of the organization, at all levels, across all geographies, and in all departments. Will establish the highest standards of ethical behavior and conduct while providing expertise, consultation and assessments in matters related to compliance, audit and risk. Will include: Consistently find opportunities to strengthen and improve the culture of compliance at the company, including by partnering with department heads to build relationships with the compliance office. Advise on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies. Review and provide advice on marketing materials and sales activities. Develop/revise policies and procedures designed to prevent illegal, unethical, or improper conduct. Responds to alleged violations of laws, regulations, policies, and procedures by evaluating or recommending the initiation of investigative procedures. Implements investigative protocols and oversees investigation process, including conducting or managing privileged compliance investigations. Establishes and implements periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk. Develops and implements preventative and corrective action plans to mitigate identified risks. Identify potential areas of compliance risk and implement corrective action plans for resolution of problematic issues. Reviewing and analyzing regulatory developments and trends and collaborating closely with legal colleagues, relevant functions, and investor relations to determine potential impact and applicability. Ensuring compliance with applicable laws and regulations by coordinating input from a broad array of external and internal experts. Provide reporting to the Board of Directors. Maintain an effective compliance communication program for the organization, including promoting:. use of the compliance hotline; (b) heightened awareness of Code of Conduct, (c) understanding of new and existing compliance issues and related policies and procedures, and (d) periodically review/update the Code of Conduct for continued relevancy.

Requirements: JD Degree with strong academic credentials. 10+ years leading global healthcare corporate compliance; medical device experience preferred. Experience dealing with regulatory and enforcement bodies including FDA, US DOJ, EMA and other international regulatory agencies and with domestic and international government agencies. Demonstrated experience with launching new compliance programs, from creation to implementation. Global experience. Deep understanding of risks facing a global medical devices company like: Anti-Bribery Anti-Corruption, 3rd party distributors, Anti-Kickback, False Claims Act, etc. Executive reporting including to Board of Directors is preferred. Able to handle complex matters, across multiple simultaneous initiatives that require discretion, confidentiality, and prioritization. Strategic business orientation and acumen and the ability to define and prioritize efforts based on business direction and needs. Strong leadership presence and polished demeanor. Dynamic and engaging communication skills - able to lead through words and actions.
 
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