Director of Compliance

Ortho Development Corporation•Draper, UT

1d•Onsite

About The Position

Director of Compliance Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in the Salt Lake City suburb of Draper, Utah. Our primary product focus is total hip and knee replacement. We are passionate about designing and manufacturing innovative, clinically proven products using the latest material science and technology. The Director of Compliance will lead and expand the company’s compliance program to ensure adherence to all applicable laws, regulations, and industry standards governing orthopedic medical device companies. This individual will develop, implement, and continuously improve a comprehensive compliance framework that supports ethical conduct, regulatory compliance, and Ortho Development’s codes of conduct and ethics. The Director will partner with cross-functional teams to integrate compliance into daily operations, enhance existing processes, and ensure a culture of integrity throughout the organization. This role is critical to maintaining Ortho Development’s reputation for high product quality and ethical management. The Director of Compliance is a hand-on leadership role reporting to the CEO. Location: Onsite - Draper, UT Schedule: Monday- Friday

Requirements

Minimum of 8-10 years of compliance experience in the medical device or healthcare industry, with at least 5 years in a leadership role.
Demonstrated experience developing or enhancing a compliance program in a highly regulated environment.
Strong knowledge of FDA regulations, OIG guidance, Sunshine Act requirements, and industry codes (e.g., AdvaMed).
Strategic thinker with the ability to design and implement practical compliance systems in a growing organization.
Proven ability to influence across functional areas and drive a culture of compliance and accountability.
Strong leadership and communication skills.
Strong analytical and problem-solving skills with the ability to assess and mitigate risks.
High ethical standards and a commitment to fostering a culture of integrity.
Proactive and adaptable, with a hands-on approach to problem-solving.

Nice To Haves

Certified Compliance & Ethics Professional (CCEP), Certified in Healthcare Compliance (CHC), or similar credentials preferred.
Occasional domestic travel may be required

Responsibilities

Compliance Program Leadership : Develop, implement, and continuously improve a comprehensive and robust compliance program tailored to Ortho Development’s size, structure, and regulatory environment.
Enhance and expand Ortho Development’s existing compliance program, ensuring optimal policies, procedures, and controls are in place across all functional areas.
Stay current with evolving regulations, industry standards, and best practices in medical device compliance, and adapt program accordingly.
Create, update, and enforce compliance policies and procedures to align with industry best practices and regulatory requirements, including those related to Open Payments, anti-kickback statutes, False Claims Act, HIPAA, and AdvaMed Code of Ethics, data privacy, and anti-corruption (i.e., FCPA).
Develop and deliver compliance training programs for employees, and leadership to promote a culture of compliance awareness and ethical decision making.
Lead Compliance Committee.
Reporting and Monitoring : Provide regular reports to senior leadership, compliance committee, and board of directors regarding compliance program effectiveness, risks, incidents, preventative, and corrective actions.
Report on emerging compliance risks and best practices.
Manage and monitor company interactions with healthcare professionals (HCPs), ensuring appropriate contracting, transparency reporting, and fair market value assessments.
Lead risk assessments audits to identify potential areas of compliance vulnerability; develop and implement corrective action plans and preventive measures.
Lead investigations into potential violations of company policies or regulations.
Manage whistleblower complaints and conflict of interest disclosures.
Maintain accurate compliance documentation, including policies, training records, audit results, and preventative and corrective action plans.
Serve as the primary point of contact for ethics-related concerns and the key liaison with regulatory agencies and external counsel on compliance matters as needed.
Cross-Functional Collaboration : Partner with Sales, Contract Administration, Product Development, Marketing, Operations, Quality Assurance, and Regulatory Affairs teams to integrate compliance into all business processes.
Ensure compliant sales and marketing practices.
Support commercial team with compliant sales strategies, proper interactions with healthcare professionals, and documentation of engagements.
Vendor and Distributor Oversight : Monitor compliance of third-party vendors, suppliers, and distributors to ensure alignment with Ortho Development’s standards and regulatory requirements.
Perform other job-related duties as assigned.