- Job Title
- Compliance Manager.343
A leading medical device manufacturer seeks a Compliance Manager in Audubon, PA. The base salary is up to $150K and is bonus eligible.
The Compliance Manager will report to the Chief Compliance Officer and will help implement and support the Compliance Program. The Compliance Manager will assist with drafting and launching clear, concise compliance policies and guidance, training employees and distributors/agents, interpreting legislation and providing guidance to senior management on compliance issues affecting the healthcare industry. The ideal person will also assist in the investigation of alleged breaches of laws, regulations and policies and perform corrective actions, coordinate compliance tracking and monitoring activities and support the efforts of the Corporate Compliance Committee. This individual will also work proactively with other departments and regions globally to assess and improve internal controls and business processes to enable the company to achieve its business goals and objectives in a compliant manner. Additional duties include the following:
- Knowledge of external regulations and requirements to key activities and processes, policies and procedures
- Identify Compliance risk areas and develop strategies to address risk areas
- Lead the creation, deployment and assignment of e-learning modules globally
- Develop training and education programs for employees. Perform in-person training of the material. Train employees on policies, changes and potential risk areas as required
- Investigate alleged breaches of laws, regulations and policies and perform corrective actions as needed
- Conduct annual company-wide Needs Assessment
- Oversee due diligence on international distributors from FCPA compliance perspective
- Assists with and support the development of the annual Compliance auditing and monitoring plans
- Assist in the oversight of audits to determine the extent of compliance and opportunities for improvement
- Provide relevant guidance and insight into policy development; and identify program enhancements to address Compliance risk areas
- Responsible for reporting business unit metrics and key performance indicators that reflect the effectiveness of the Commercial Compliance program
- Provide support to Chief Compliance Officer on Corporate level initiatives, as needed
- Review and support, when applicable, Compliance investigations as required and ensure appropriate resolution and, corrective action, as appropriate
- Draft and revise critical Compliance policies
- Oversee Sunshine Reporting and Global Transparency Reporting
- Data Privacy
- Assist and ensure conformance with Compliance related matters in M&A projects from the due diligence phase to final integration
- Develop and ensure implementation of the compliance communication strategy to foster a values-based culture
- Bachelor’s degree combined with 3 to 5 years of healthcare compliance experience with a medical device or pharmaceutical company.
- JD or Masters, desired but not required. HCCA or Seton Hall Healthcare Compliance preferred.
- Ability to manage and implement change.
- Proven leadership skills in developing, direction, organizing, managing coordinating and monitoring complex processes.
- Demonstrated knowledge of legal, regulatory and political environments in the compliance areas.
- Ability to build and manage relationships with business partners and Compliance colleagues.
- Exceptional communication and presentation skills required, with demonstrated success inspiring confidence and support for Compliance initiatives across stakeholders.
- Ability to thrive in a fast-paced, innovative environment with the ability to handle multiple, conflicting priorities while managing a substantial workload.
- Highly self-motivated, with the ability to quickly gain trust and credibility from team members and stakeholders.
- Strong team player that is customer and solution-oriented, with the ability to understand and differentiate approach to complex compliance matters.
- Business travel up to 20% of time
Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without unlawful discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.