AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient’s quality of life.
AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.
AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.
The Compliance Specialist will support the implementation and monitoring of AxoGen’s Compliance Programs primarily related to business practices and regulatory practices. These include, but are not limited to, the Code of Conduct, Business Conduct Standards and other AxoGen policies, government regulations and laws (foreign and domestic), and the domestic and international Code of Ethics.
The Compliance Specialist will be responsible for AxoGen’s complaint and pharmacovigilance system. These responsibilities will include development of reports, both internal and to government agencies. The Compliance Specialist will interact with Sales and Customer Care to obtain information, interact with Quality and Operations for investigations and interact with Regulatory and Clinical for clinical investigations.
Educational Requirements / Qualifications
- BS in relevant scientific discipline, advanced degree and/or a degree/certificate in project management a plus.
- 1-4 years’ experience in compliance activities
- Experience with Microsoft Office, Microsoft Project and Microsoft 365.
- Knowledge of medical device, human tissue or biologics products compliance activities
- Understanding of the healthcare compliance regulations
- Strong interpersonal skills requiring the ability to resolve conflicting interests and obtain cooperation
Primary Responsibilities: The specific duties of the Compliance Specialist include but are not limited to:
- Serves as compliance subject matter expert when issues or questions arise
- Assist with the development and implementation of company compliance policies and procedures
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
- Conduct or direct the internal investigations of compliance issues
- Assess product, compliance or operational risks and develop risk management strategies
- Responsible for Product Complaint system and Pharmacovigilance system including receipt, investigation and closure of events.
- Report domestic and international adverse events to appropriate regulatory authorities
- Responsible for domestic (state and federal) and international company registrations/permits related to healthcare products.
- Responsible for compliance to Open Payment program and CMS regulations surround Open Payment.
- Responsible for AxoGen’s Grant Program
- Interpret new and existing regulatory requirements as they relate to our products and initiate actions to assure compliance to these regulations.
- Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals.
- Implement process improvements for compliance processes, systems, and/or controls. Provide insightful input during the development of compliance programs and strategies.
- Analyze data and report trends to management
We are seeking candidates who are AxoGenic, which means:
- Respect is the foundation for communication and action.
- Patient safety is our first priority.
- In being effective stewards of the gift of human tissue.
- In creating and maintaining a company culture that encourages and rewards honesty, openness, passionate debate – and fun!
- Individual ownership and empowerment lead to superior team results.
- The organization, its members and partners must consistently achieve agreed upon results with flexibility and mutual support.
- Speed is critical!