Princeton Legal Search Group has been engaged on an exclusive basis by a growing Medical Device company in New Jersey. We are leading the search for a Sr. Manager, Global Compliance (Policies & Training). This position will be a member of the Global Compliance team, providing day-to-day management of compliance program initiatives. This role will have direct responsibility for implementing and maintaining specific compliance areas, including the Company’s compliance policies, SOPs, compliance communication and awareness materials, and training on compliance policies and the Hoya Code of Conduct.
This individual must be knowledgeable of current US laws and regulations relevant to the Company’s compliance program, including federal and state fraud and abuse and anti-kickback statutes, federal and state transparency laws, OIG Guidelines and state marketing compliance laws.
- Partner with multiple stakeholders such as legal, HR, operations, internal audit, QA/RA, sales and marketing to develop, operate, and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are developed, updated and maintained throughout its life-cycle.
- Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements.
- Provide consistent and comprehensive compliance training to all Company employees through multiple delivery channels, including in-person, webinar and online. This role will serve as the Company’s business owner of the compliance LMS, including maintenance, user administration and business support and work closely with other training and compliance professionals within the Company and Hoya to optimize the user experience and learning.
- Develop curriculum, training plans, and training completion reports in support of the compliance training program.
- Become familiar with and develop an understanding of relevant laws and regulations in key global markets to ensure that the Company’s policies are in compliance with such laws and regulations.
- Assist the Chief Compliance Officer to continue to embed a culture of ethics and compliance
- Serve as a resource and subject matter expert for all compliance related activities.
- Assist the Chief Compliance Officer on such other projects as assigned from time to time.
- Bachelor’s degree from an accredited institution.
- 10 plus years progressive overall experience. Minimum of seven years with Compliance or QA/RA in medical device or life science industry.
- Strong knowledge of key laws and regulations impacting the medical device or life science industry (e.g., AKS, Sunshine Act).
- Team oriented, problem solving and ability to work in a fast paced, rapidly changing environment.
- Strong verbal and written communication skills, as well as excellent public speaking skills.
- Ability to work evenings and early mornings to accommodate telephone meetings with colleagues in Asia-Pacific and Europe.
- Willingness to undertake some travel, including international travel, in support of compliance responsibilities and initiatives.
- Professional certification (e.g. Certified Compliance & Ethics Professional (CCEP)) is a plus.