This job listing has expired and the position may no longer be open for hire.

Regulatory Affairs Specialist at American Orthodontics Corp in Sheboygan, Wisconsin

Posted in Information Technology 30+ days ago.

Type: Full-Time





Job Description:

Job Summary:

Lead efforts to ensure compliance with all regulatory agencies.  Support all functions relating to regulatory affairs.  Coordinate activities to obtain and maintain product registrations (domestic and international).

Duties & Responsibilities:


  • Lead and support product registration for both domestic and international customers

    • Coordinate efforts associated with the preparation of regulatory documents and submissions

    • Coordinate and prepare regulatory submissions for domestic or international projects

    • Prepare additional information or responses as requested by regulatory agencies

    • Communicate with customer service, and international customers


  • Prepare and maintain technical files as necessary to obtain and sustain product approval

  • Support Engineering and PDS teams to successfully complete and obtain product registrations

    • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards

    • Communicate with regulatory agencies


  • Participate in internal and external audits

  • Perform additional responsibilities as requested to achieve business objectives

Qualifications:


  • High school diploma or equivalent required; relevant Associate Degree desired

  • Experience working in a regulated industry desired

  • Demonstrated strong internal structure to successfully lead multiple activities simultaneously

  • Demonstrated accuracy and thoroughness

  • Ability to interpret regulations and apply the regulations to the organization

  • Proficient with the Microsoft Office Suite, especially Excel

  • Strong written and verbal communication skills

See job description





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