Compliance Manager LDR Spine USA, Inc.
THIS JOB HAS EXPIRED The Compliance Manager is responsible for implementing, managing, and improving LDR's corporate compliance program. The Compliance Manager will help ensure that LDR's compliance program is consistent with applicable laws, industry standards, and company policies; that LDR and its employees and partners are compliant with federal, state and local statutes, regulations and rules pertaining to the company's operations as a medical device company, including but not limited to the company's sales, marketing and promotional activities; and that LDR's compliance policies and procedures are followed. The Compliance Manager will assist the Compliance Officer in defining compliance standards via policies and procedures, training, auditing and monitoring, responding to reports of alleged compliance violations, and conducting compliance-related investigations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assist the Compliance Officer and Compliance Committee with developing, implementing and monitoring of appropriate compliance-related policies and procedures;
Monitor compliance with the Company's Code Conduct and policies and procedures;
Manage the Company's compliance processes for interactions with health care professionals; all contribution and grant requests for compliance and monitor the review and approval process;
Approve of consulting services with health care professionals, payment of fees and reimbursements to health care professionals;
Manage the Company's compliance with the Physician Payment Sunshine Act and similar state acts;
Lead compliance training functions, including creating and preparing a training program, working with outside training vendors, preparing materials for new hire orientation, and conducting training sessions as needed;
Track compliance requirements of State and federal governments and ensure reporting requirements are followed in accordance with all applicable laws;
Track, keep informed, and communicate to the Compliance Officer and other executives and employees, as appropriate, all changes in the government regulations and industry codes;
Assist with compliance-related investigations;
Answer employee questions about the Company's compliance program, policies and procedures;
Keep Compliance Officer informed of all compliance-related issues
Develop materials for Compliance Officer's reports to other executives and the Board of Directors;
Manage Compliance Administrator;
Other duties may be assigned.
Bachelor's degree, advanced degree preferred.
two years of medical device or pharma compliance experience
three to five years of management/supervisory experience
Experience with and understanding of compliance issues facing medical device and/or pharma companies
Strong knowledge of business ethics
Proficient in MS Word, Excel and Powerpoint (Access, Adobe Forms, as plus)
Knowledge and understanding of the Anti-Kickback Statute, the False Claims Act, AdvaMed Code, and the Physician Payment Sunshine Act
Strong verbal and written communication skills including ability to interact positively with a wide variety of individuals
Decisive and able to exercise good judgment under pressure
Demonstrated ability to work independently and as part of a team to accomplish project goals
Strong interpersonal skills to interact with employees of all organizational levels
Demonstrated ability and willingness to learn
Strong organizational skills
Sound decision-making ability taking into account all information and utilizing a "big picture" approach
Demonstrated experience identifying and resolving compliance and legal issues quickly and effectively
Demonstrated experience prioritizing conflicting demands in a fast-paced environment
Some travel throughout the United States is required. Some international travel may also be necessary.
THIS JOB HAS EXPIRED
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.
> 50M RaisedInvestors: Austin Ventures
, PTV Sciences
, Rothschild Private Equity
, Telegraph Hill Partners All Jobs: at LDR Spine USA, Inc.
|Headquarters:||13785 Research Boulevard|
Austin, TX 78750
|Industry:||Medical Devices and Equipment|
|Company Profile:||Vision: LDR combines passion and innovation to improve spine care.
Mission: LDR develops and markets total spine solutions for patients and the surgeon community worldwide. We listen to surgeons and use our technical experience and passion for improvement to create innovative spine products.
2001- LDR Medical, SAS
2004- LDR Spine USA, Inc.
2006- LDR Holding Corporation
Ownership and Financing:
Primary Investors: Austin Ventures, PTV Sciences,
Rothschild Private Equity and Telegraph Hill Partners
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