Base Salary: $80,000 - $150,000
Bonus Potential: 20% of Base Salary
401k Option: Company also provides a up to matching contribution option
Healthcare Benefit Options: Medical, Dental, Vision, Flexible Spending Account and Dependent Care Insurance: Life and Disability Insurance
Paid Time Off: Vacation and Sick paid days off are available
Expense Information: Company pays for all business-related expenses (compliance regulations apply)
As the Compliance Manager, this position would be responsible for leading all business practices within our clients organization. and ensuring components are in compliance with all internal policies, local laws and regulations, and relevant industry standards. The Compliance Manager would also oversee company Compliance program which is committed to the company ethical and legal compliant process.
Key Success Indicators: Regulatory Compliance
Key Success Indicators: Company Ethics
- Maintain documentation related to the operation of the Compliance Program including, but not limited to the Compliance Plan, the Code of Conduct, policies and procedures and educational materials. Organize revisions to the Compliance Plan or Code of Conduct as necessary in order to respond to the changing needs of the company and changes in the laws, rules and regulations governing by the Company.
- Serve as an advisor to senior management and all other employees with regard to compliance-related matters and promote the company’s commitment to compliance and those ethical values that are displayed in the Compliance Program
- Arrange the development and execution of an effective compliance training program that includes, but is not limited to, compliance training of new employees, addressing specialized training needs and providing periodic training for existing employees."
Key Success Indicators: Risk Management
- Partner with company leadership to ensure the compliance program effectively stops, detects, and reacts to violations of law, regulations, policies and industry standards
- Maintain a working understanding of relevant compliance issues, laws and regulations. Administrate the dissemination of information on health care regulatory and legal developments affecting the company daily operations
- Make ethical and legal decisions by comprehending and applying complex law regulations to a variety of scenarios ensuring the best outcome is made during a compliance concern
- Work with the Human Resources department to define appropriate compliance and ethics goals and objectives for leadership and assure failure in reporting incidents is in violation of the Compliance Program
- Monitor the performance of the compliance and ethics program and periodically make revisions to the Compliance & Ethics Program, Compliance Plan, and Code of Conduct"
- Develop a strategic global training and communications program to offer employees company-wide a clear understanding of company values and the legal risks it faces as well as the policies and procedures the company has implemented to mitigate risks, comply with the law, and make ethical decisions
- Conduct investigations and manage the entire investigation process including management and tracking of the investigation lifecycle and finalize phrase process
- Robust business and financial acumen with a clear understanding of core business processes while executing action plans to handle issues identified in risk assessments and in investigations"
Our client is an EO employer – M/F/Veteran/Disability. "We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."
- Bachelor’s degree is required, preferably with a major in Life Science, Business, Marketing, or an related field
- A minimum of ten years of experience working in the healthcare industry
- A minimum of seven years with Compliance or QA/RA in the medical device or life science industry
- Outstanding skills/proven track record in writing and modifying departmental SOPs
- Thorough understanding of healthcare compliance laws, regulations and standards applicable to medical device companies, including those addressing anti-corruption/anti-bribery, privacy and medical device promotion
- Strong knowledge of key laws and regulations impacting the medical device or life science industry (e.i.: Sunshine Act)
- Ability to operate with a high level of sensitivity and confidentiality
- Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism
- Must complete a successful background check and drug screening
- Legally authorized to work permanently in the U.S. and not require sponsorship for employment visa status now or in the future