Compliance Specialist

Embla Medical; Irvine (CA); On-site; USD 61,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision Benefits

401(k) Retirement Plan with employer-m

Bonus potential

Job summary

Embla Medical is seeking a Compliance Specialist to assist the Director of Compliance in managing the Americas compliance program across Embla Medical’s business units. This role includes auditing, reporting, training coordination and ensuring adherence to state and federal regulations related to medical devices and the company code of conduct.

The position requires building a culture of ethical conduct, handling confidential information with discretion, and collaborating with business leaders

Qualifications

• Experience with risk assessment, controls development, training, monitoring and reporting.
• Knowledge of state and federal medical device laws and regulations.
• Ability to handle confidential information with discretion.
• Strong analytical and communication skills.
• Preferred: Bachelor's degree in a related field and 2–4 years in healthcare compliance.

Responsibilities

• Support administration and improvement of the Americas compliance program.
• Audit and monitor activities across Americas units, track findings and assist action plans.
• Manage compliance systems and platforms, including transparency reporting.
• Coordinate compliance training and track completions.
• Promote ethical conduct and compliance culture.

Skills

Risk assessment

Controls development

Training & monitoring

Data analysis

Discretion

Communication skills

Team collaboration

Education

Bachelor's degree in a related field

Job description

About Us

Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Significant ongoing investment in research and development has led to over 2,100 patents, award-winning designs, and successful clinical outcomes. Össur is focused on improving people’s mobility through the delivery of Prosthetics and Bracing & Supports solutions. Helping people live a Life Without Limitations is why we exist as a company.

About The Role

The Compliance Specialist is responsible for assisting the Director of Compliance in the management of the compliance program for Embla Medical’s 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 company’s code of conduct.

What You’ll Do

• Support the administration and continuous improvement of the Americas compliance program, including compliance systems, processes, documentation, and reporting
• Assist with auditing and monitoring activities across applicable Americas business units, including tracking findings, documenting results, and supporting corrective action plans
• Manage compliance systems and platforms, including transparency reporting
• Help coordinate compliance training and education, including training assignments, completion monitoring, reminders, records, and escalation of overdue assignments
• Ensure that compliance controls operate effectively across the relevant business units and collaborate with business leaders as appropriate
• Promote a culture that encourages ethical conduct and a commitment to compliance
• Develop 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
• Explain 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.

Who You Are

• 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 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.
• 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.
• Preferred Qualifications:
  • 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

Why You’ll Feel Good Working Here

• We value a diverse working environment and a welcoming and fun company culture
• We empower our colleagues and encourage close collaboration, allowing us to develop the best products and maintain the highest possible standards of care
• Competitive Compensation and Benefit Packages
• Medical, Dental, and Vision Benefits
• 401(k) Retirement Plan with employer matching contribution

The US base pay range for this full-time position is $61,123 - $95,394 + bonus + benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire pay rates. 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.

Embla Medical is committed to sustainable business practices and renowned for positively impacting people‘s health and well-being

Embla Medical is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available individual in every job.

Embla Medical's equal opportunity policy prohibits all discrimination (based on race, color, creed, sex, religion, marital status, age, national origin or ancestry, physical disability, mental disability, military service, pregnancy, child birth or related medical condition, actual or perceived sexual orientation, or any other consideration made unlawful by local laws around the world).

Embla Medical is committed to complying with all applicable laws providing equal employment opportunities. This commitment applies to all individuals involved in the operations of Embla Medical and prohibits discrimination by any emplo yee of Embla Medical, including supervisors and co-workers.

Important Warning:

Beware of fraudulent recruiters impersonating our company. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. We will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official website.