Why Orthofix?
We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!
How you'll make a difference?
The Director of Compliance, Bone Growth Therapies, US Orthopedics ("Director") will assist the Sr. Director Global Compliance in managing, developing, and implementing various compliance initiatives for the U.S. business units. The Director will provide Compliance guidance to Bone Growth Therapies, US Orthopedics personnel in the United States. The Director will promptly respond to Compliance questions and concerns and will build strong relationships with commercial and operational personnel in the Bone Growth Therapies and US Orthopedics businesses. The Director will focus on developing and improving policies, procedures, training, education, investigational protocols, and monitoring systems in the U.S.
The Director, in coordination with other members of the Compliance Department, will also be responsible for investigating hotline reports, responding to general compliance questions and concerns, analyzing data metrics, conducting due diligence and conflicts-of-interest reviews on U.S.-based sales agents, distributors and other third parties, and monitoring and auditing certain activities of the Bone Growth Therapies, US Orthopedics business units in the United States. The Director will communicate with Bone Growth Therapies, US Orthopedics leadership regarding compliance concerns, risk assessments, and other compliance initiatives. The Director will serve as the Company's point of contact for maintaining its ACHC accreditation status and will provide direction to Compliance Operations personnel to ensure the company's accreditation remains current. The Director will review, research, recommend and present Grant requests to the Grant Committee for U.S. grant requests. As requested by the Sr. Director Global Compliance, the Director may prepare and/or present materials for Executive Compliance Committee Meetings and periodic meetings of the Board-level Compliance Committee. The Director will prepare materials, coordinate, and/or organize Compliance presentations for regional and national sales meetings. The Director will review privacy questions, review data and privacy breaches related to HIPAA and state privacy laws, make filings with the Office of Civil Rights and act as the US Privacy Officer for the Company. Finally, the Director will conduct periodic ride-alongs and take any steps the Sr. Director Global Compliance deems necessary to ensure that Orthofix has implemented and maintained appropriate internal controls to ensure compliance with applicable laws, including the Stark Law, the False Claims Act, the federal Anti-Kickback Statute and the Foreign Corrupt Practices Act.
What will your duties and responsibilities be?
- Regular attendance, as defined by Sr. Director Global Compliance, required.
- Serve as a compliance resource for the Bone Growth Therapies, US Orthopedics Businesses.
- Draft, update and revise policies, work instructions and manuals used by U.S. employees and third parties.
- Prepare training materials based on existing policies and industry best practices.
- Monitor and ensure dissemination of policies, procedures, and training to domestic personnel.
- Review reports on monitoring and auditing activities and recommend and implement changes and process improvements accordingly. Prepare status reports on certain monitoring and auditing activities as may be requested. Conduct training and education based on risks identified through monitoring, observations, and reports.
- As applicable, support Compliance Department personnel to ensure that Compliance components are implemented, and deadlines met regarding government-imposed obligations and agreements. Conduct field observations (or "ride-alongs").
- Conduct and document compliance investigations, report inquiries from Orthofix's Ethics Hotline to Sr. Director Global Compliance and work proactively towards timely completing the investigation.
- Partner with the U.S. commercial and operational leadership to review compliance concerns and initiatives.
- With the support of Compliance Operations, manage the company's adherence to ACHC accreditation standards and readiness for periodic ACHC reviews and audits.
- Prepare content and/or organize Compliance presentations for regional and national sales meetings.
- Participate in the Grant Committee activities by reviewing and researching Grant Requests related to Bone Growth Therapies and US Orthopedics businesses and making recommendations to the Grant Committee to approve or deny the Grant Request.
- Proactively identify areas of improvement for Orthofix's Compliance Program and AKS implementation activities and participate in the development of performance improvement projects.
- Serve as the HIPAA and US Privacy Officer for the Company.
- Perform other duties as assigned.
What skills and experience will you need?
- Legal experience and Juris Doctorate degree required.
- Internal audit experience desirable.
- Experience in durable medical equipment (DMEPOS) compliance, medical device or pharmaceutical industry preferable.
- Experience in preparing effective presentations and reports using a variety of software programs.
- Excellent oral, written and interpersonal communication skills, with the ability to convey a positive and professional image in person, on the telephone, and in written communications with all levels of the organization and agents and representatives of the company.
- Attention to detail in all written communications.
- Sensitivity to confidential matters and ability to maintain strict confidentiality of employee, patient, and company information.
- Thorough and detailed understanding of health care compliance concepts preferable.
- Experience in a compliance function preferable.
- Willingness to constantly learn to maintain current knowledge with respect to assigned areas.
- Demonstrated commitment to assumed or assigned responsibilities.
- Ability to effectively collaborate with others at multiple organizational levels.
- Strong problem-solving skills.
- Strong work ethic.
- Some travel is required.
What skills and experience would be preferred?
- Certification in Healthcare Compliance (CHC)
- Familiarity with Orthofix processes and procedures
PHYSICAL DEMANDS AND WORK CONDITIONS:
The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
- No additional physical requirements or essential functions for this position.
The anticipated salary for this position for an employee who is located in California is $168,013.00 to $216,803.00 per year, plus bonus, based on performance, equity, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
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