A large Electrical/Electronic Manufacturing company is looking for a Director of Regional Compliance Programs. See job description below.
Compliance program development experience a major plus.
Need to develop an inventory of disparate, decentralized compliance program and then develop a plan to manage them and close any identified gaps.
Medical device or pharama experience is a major plus since that is 60% of their business.
They have a large capital equipment sales and service business with clients in every industry segment.
Sunshine laws in CA is a significant compliance factor for them.
Ideal candidate will know how a large company runs but be resourceful and be able to adapt in a matrix organization.
Ability to develop a roadmap for their US compliance. Programs include ISO9001 and Environmental audits.
Ability to develop a strategic plan for compliance and localize individual aspects of it.
Form a compliance committee.
Board room as well as staff level communication skills.
Willingness to travel (perhaps a lot in the first year).
Develop/improve and maintain structures and processes to ensure adherence of regional entities to a comprehensive master compliance calendar (including training and auditing)(in conjunction with LCO’s /regional compliance council).
In conjunction with legal representatives, assist in the monitoring and interpretation of laws, regulations and trends that may have implications for the compliance program, and, as appropriate, direct and advise LCO’s and Management of the same.
Develop/improve, implement, and publicize a central system whereby employees and third parties may report or seek guidance regarding reporting potential or actual criminal conduct, fraud or other forms of improper behavior without fear of retaliation (e.g.: Compliance Hotline).
Independently review and supportinvestigation of potential violations of the Code of Conduct; work with LCO/Management and Human Resources to determine appropriate remedial or disciplinary measures.
Work with Corporate Auditing/Risk Management (CAR) and Corporate Compliance Office to assess performance in specific compliance areas and to help develop the annual audit plan, develop and maintain a system of performance benchmarks for compliance, and periodically evaluate and report on the effectiveness of the compliance and ethics program.
Develop/improve, coordinate, and participate in a multifaceted educational training program that focuses on the elements of the compliance program (defined by law and Code of Conduct), and seeks to ensure that all appropriate personnel have knowledge and comply with legal, ethical/brand, and regulatory obligations.
Promote professional development and training of LCO’s and Management with compliance responsibilities, (including, e.g.: disseminating information, arranging conferences, on-line education).
Master’s in an appropriate specialization combined with five years of relevant experience; or J.D. combined with five years of relevant experience; or bachelor's degree in an appropriate specialization and ten years of relevant experience.
Experience in corporate compliance for organizations serving a customer base which includes HCP’s, government agencies, private and public corporations.
Demonstrated ability to advise senior management and governing board on enterprise-level compliance risks.
Excellent oral and written communication skills including the ability to communicate complex compliance issues to any level of employee; excellent education and training skills; and excellent ability to collaborate with others to achieve goals.
Ability to work well self-directed and ability to collaborate, facilitate the work of a team of professionals.
Demonstrated ability to effectively design and implement compliance department operations; ability to de-construct complex legal requirements and create compliance policies and procedures that are clear, effective, succinct, and sustainable; and demonstrated knowledge/ability in compliance process improvement.
Medical/ Pharmaceutical experience strongly preferred
Travel (both domestically and internationally) ~40%