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…

Job Type: Full-time

Pay: $77,000.00 - $96,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift

Work Location: Hybrid remote in Irvine, CA 92618