Regulatory Compliance Specialist

4 weeks ago

Saint Paul, United States AbleNet, Inc. Full time

POSITION SUMMARY:

The Regulatory & Compliance Specialist is responsible for overseeing AbleNet’s organizational compliance with government laws and regulations. Their duties include coordinating with company management to identify potential risks, implementing policies and procedures to uphold laws and regulations and monitoring the company’s adherence to those policies and procedures. The Project Manager, Regulatory & Compliance collaborates and coordinates with internal and external stakeholders to ensure all compliance and regulatory responsibilities are completed and managed in a timely, accurate, and responsible manner. The role is also responsible for assessing quality control issues associated with products based on cases captured by the ableCARE staff. The responsibilities associated with the role are managed through compliance software, incident/case management and quality control issues documented in Salesforce. It is essential that this role supports the AbleNet guiding principles and emulates those principles with both internal and external stakeholders.


POSITION RESPONSIBILITIES:

  1. Track/Monitor internal company policies and ensure all policies are managed and implemented.
  2. Make sure the organization has a clearly defined program for complying with various country’s laws as well as the laws of CMS/Noridian.
  3. Study ableCARE cases to determine quality control issues or concerns for discussion with management
  4. Work with product management to ensure products meet all compliance and regulatory responsibilities
  5. Report to management concerning the organization’s compliance with laws and regulations.
  6. Act in dealing with noncompliance situations, creating realistic plans to overcome them.
  7. Conduct regular audits to identify potential weaknesses and noncompliance situations.
  8. Communicate with employees and make sure everyone is aware of what they need to do to comply with internal and external laws and regulations.
  9. All other duties as assigned


CORE COMPETENCIES, SKILLS & ABILITIES:

  1. Attention to detail and ability to ensure AbleNet staff is held accountable for all internal policies and compliance responsibilities
  2. Ability to prioritize and meet deadlines
  3. Strong written and verbal communication skills
  4. Ability to work with external partners – regulatory agencies
  5. Ability to work with internal and external stakeholders
  6. Understanding a compliance software and Salesforce case management
  7. Ability to use Microsoft Office (Word, Excel, PowerPoint, Outlook), Solidworks and Creo CAD software, Arena product management software, and Adobe Creative Suite
  8. General knowledge of global regulatory requirements and the ability to research new regulatory requirements


POSITION REQUIREMENTS:

Education & Experience


  • Bachelor’s degree required and/or
  • 5-7+ years of regulatory and compliance management




Physical, Time, Presence & Other Requirements

Physical:

Up to 8 hours of computer keyboarding per day

Time:

Full-Time, Exempt employees work an average of 40 hours per week. Additional hours may be required as necessary.

Presence:

Full-time onsite presence is required during introductory onboarding and training period; hybrid or remote arrangements will be considered upon completion.

Travel:

Up to 10% of domestic travel may be expected

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