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Ossur North America is Hiring a Compliance Specialist Near Irvine, CA
Basic Function: The Compliance Specialist is responsible for assisting the management of the compliance program for the Össur Americas Business Units. This role is responsible for management of compliance functions that ensure that the organization follows state and federal regulations including state insurance laws, federal laws and regulations and the AdvaMed code of conduct. Responsibilities: Provides practical, solutions-oriented compliance advice, guidance, and representation to the company and its related entities. Oversees auditing and monitoring of compliance with relevant laws, regulations, and corporate policies across the US, Canada and Mexico – the Americas. Manages day-to-day administration of the organization’s compliance program Assist in managing Americas Compliance Committee and materials for the Quarterly Compliance Committee Meetings Ensure that agendas and policy issues are vetted and addressed in Quarterly Compliance Committee Meetings, follow-up items are addressed and that policies or procedures are created if any weaknesses are found to mitigate risk Ensure that compliance controls are operating effectively across the relevant business units and collaborate with business leaders as appropriate Promotes a culture that encourages ethical conduct and a commitment to compliance Develops policies and programs that encourage managers and employees to report compliance issues Recommend and/or implement control enhancements when control deficiencies are identified. Ensure company-wide communication of compliance policies and procedures. Collaborate in the development, implementation and monitoring of compliance education and training Act as a key contact to key stakeholders’ associates for all compliance-related questions or concerns Explaining such regulations, policies and procedures to company personnel and assist the product implementation teams in the development of related business requirements All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific. All training related to the quality management system is done in accordance to the Training Management Process (QM1681). Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative at all times. Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards. Qualifications/Education Requirements: Bachelor’s Degree in degree in related field 2-4 years of relevant working experience in healthcare compliance preferably in medical device or pharma industry setting Basic knowledge in risk identification, risk assessment, controls development, training, monitoring, and reporting. Basic understanding of the laws and regulations that impact medical device companies such as anti-kickback, sunshine act, false claims act, stark law, consumer protection laws, FDA, FCPA and AdvaMed. Basic understanding of medicare, medicaid and private payor relationships and reimbursement issues such as medical necessity, local coverage decisions and claw back provisions. Basic understanding of DOJ enforcement actions, corporate compliance guidance and corporate integrity agreements. Ability to use discretion and independent judgment to manage and impart confidential information. Knowledge of local, state, and federal laws, regulations, and legislation, especially related to medical device sales. Demonstrated ability to develop policies and procedures. Supervisory, employee development, and leadership skills. Strong critical thinking skills and the ability to analyze, summarize, and effectively present data. Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies. Demonstrated understanding of compliance systems and controls. Experience explaining compliance risks to sales and marketing teams. Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals may need to sit or stand as needed. May require walking primarily on a level surface for periodic periods throughout the day. Reaching above shoulder heights, below the waist or Lifting as required to file documents or store materials throughout the work day. Proper lifting techniques required. May include lifting up to 25 pounds for files, computer printouts on occasion. The US base salary range for this full-time position is $77,000 - $96,000 bonus benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus or benefits. Benefits we offer: Referral Bonuses Paid Sick and Vacation Time 401(k) plan with Company Match Medical, Dental & Vision Insurance Wellness Program - Save Up To 30% In Your Medical Premiums Company Paid Life Insurance Affordable Short- & Long-Term Disability Insurance Affordable Accidental and Critical Illness Insurance 10 Paid Holidays Give Back Program – Paid Time Off To Volunteer Tuition Reimbursement Annual Performance Reviews We Provide A Flexible Work Environment To Offer Work/Life Balance And Much More… Össur is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Important Warning: Beware of fraudulent recruiters impersonating Össur. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. Össur will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official Össur website at https://www.ossur.com/global/about-ossur/careers-at-ossur Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Founded as an Orthotic & Prosthetic (O&P) clinic in 1971, Össur has a strong purpose rooted in positively impacting people’s health and well-being. Over the years, we’ve innovated award-winning solutions and grown into a leading global healthcare player with a vast network of clinics, all connected by our mission to improve people’s mobility. Our People The way we work is unique. We empower our colleagues worldwide and encourage close collaboration, allowing us to develop the best products and maintain the highest possible standards of care. Our values – honesty, frugality and courage – are the glue that binds us together and form the foundation of our company culture. Joining Össur is not just about doing your job, it’s more than that. The patients we care for depend on us to help them get back their freedom and livelihood. That is what drives us all to go to work, each day. If you are interested in joining our global team of talented individuals, please submit your information and resume for review. CLICK HERE to view global opportunities at Össur. If you experience any technical issues please contact: workdaysupport@ossur.com
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