Compliance Manager

Position Overview

Reporting to the Sr. Director of Quality Assurance / Regulatory Affairs – Compliance Officer, the Manager, Compliance will serve an important role in Ceribell’s continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Ceribell’s compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Manager, Compliance will also have primary responsibility for executing key elements of Ceribell’s auditing and monitoring program and ensuring compliance with US and global transparency requirements.

What You'll Do:

General

• Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems, programs and processes
• Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, Sunshine Act, AdvaMed Code of Ethics, transparency reporting and company policies
• Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance

Transparency Reporting

• Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
• Maintains understanding of disclosure laws, regulations and applicable industry codes

Auditing & Monitoring

• Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
• Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies
• Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed

What You'll Need:

• Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 5+ years in compliance, audit and/or other related experience required. Medical Devices or Pharmaceutical experience required
• Certified in Healthcare Compliance (CHC) or Project Management Professional (PMP) a plus
• Knowledge of and experience with laws, regulations, and industry guidance that affect the medical device or pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, AdvaMed Code of Ethics or PhRMA guidelines
• Experience with US and global transparency reporting
• Experience developing and executing audits and monitoring
• Strong operational and project management skills required
• Excellent organization, communication and presentation skills. 
• Candidate must have strong team orientation and problem-solving skills
• Candidate must be able to work independently and prioritize multiple demands

What We Offer:

• $150-160K + Bonus+  Ceribell Equity 
• 100% Employer paid Health Benefits for the Employee 
• Life & Long-term disability insurance paid 100% by Ceribell
• Flexible paid time off
• 11 Paid Holidays
• Maternity and Paternity Leave 
• Fantastic culture with tremendous career advancement opportunities