Director, Healthcare Compliance - Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The summary section provides a high-level overview of the role, giving candidates a clear understanding of its purpose and impact within the company. It should include key aspects such as the primary function of the position, how it contributes to the organization, and any relevant details about the work environment or team structure. This section helps set expectations before diving into specific responsibilities and qualifications. 

In This Role, You Will:

• Implement, maintain, and supervise the Healthcare Compliance Program
• Develop, initiate, maintain, and revise policies and procedures for the general operation of the Healthcare Compliance Program and its related activities to globally prevent illegal, unethical, or improper conduct
• Develop compliance training materials and perform ongoing compliance training for all affected employees, vendors, suppliers, consultants, and key stakeholders
• Collaborate with all cross-functional departments including Sales, Marketing, R&D, Regulatory, Clinical and Medical Affairs, Finance, People, IT, Legal, etc., to direct compliance issues to appropriate existing channels for investigation and resolution.
• Respond to alleged violations of rules, regulations, policies, and procedures by evaluating or recommending the initiation of investigative procedures. Provide ongoing advice and resources to management for compliance issues and process monitoring and improvement, and work with management to implement these improvements.
• Institute and maintain an effective compliance communication programs for the organization, including promoting: (a) appropriate use of the compliance hotline (Your Voice), (b) heightened awareness of the Healthcare Compliance Policy, and (c) understanding of new and existing compliance issues and related policies and procedures.
• Maintain the strictest confidentiality
• Report to the Board of Directors at regular intervals

Who You Will Report To: 

• See Organizational Chart

Requirements:

• Education: Bachelor’s degree in a related field required
• Minimum of 8 years’ experience in a healthcare role and/or healthcare compliance.
• Work location: Pleasanton, CA
• Travel: 25%
• Full time employment
• Demonstrated leadership ability
• Excellent analytical, written/oral communication and interpersonal skills
• Strong computer skills including Excel, PowerPoint and Word
• Strong understanding of current industry codes of conduct, including AdvaMed, EucoMed and other global medical device company guidelines.
• Familiarity with laws, regulations and standards governing medical device companies (e.g., Anti-Kickback Statute, FDCA, FCPA, UK Bribery Act, prohibition of off-label promotion)
• Exceptional customer service (internal and external) and interpersonal skills with ability to handle difficult interactions; identify the problem and escalate issues as appropriate.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary of $160,000 - $200,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpo