Quality Systems and Regulatory Affairs Specialist

Location: Corporate Headquarters, Twinsburg, OH

Summary

Reporting to the Manager, Regulatory Affairs, the Quality Systems and Regulatory Affairs Specialist will focus primarily on implementation of HMSA RA/QA programs. Including but not limited to the creation, preparation, and accomplishment of regulatory submissions, investigating customer complaints, and related quality system activities.

Essential Functions and Responsibilities

  • Assist RA Manager in writing and preparing document packages for regulatory submission
  • Help investigate product complaints and maintain complaint records
  • Assist the Manager, Quality Systems in compliance activities and QA processes for all HMSA departments
  • Help maintain the quality and regulatory document control system
  • Effect and/or coordinate internal and external quality audits
  • Work with other departments in the development of efficient RAQA compliance strategies
  • Research, prepare, and report on quality and regulatory changes that affect the business
  • Effect and/or coordinate efforts to ensure company compliance with applicable regulations

Qualifications/Skills

  • Strong working knowledge of medical devices, procedures, and terminology.
  • Working knowledge of product development process and design control.
  • Working knowledge of complaint handling and corrective and preventive action processes.
  • Working knowledge of quality system regulations.
  • Experience with Microsoft® Word, Excel, Visio, and Access or equivalent software.

Education/Experience

  • Bachelor's Degree (B.S./B.A.) or equivalent work experience in a scientific or technical discipline.
  • Minimum four (4) years of experience in Quality/Regulatory Affairs and related fields.
  • Minimum four (4) years of experience in interpreting FDA and Health Canada regulations.

Physical Requirements/Working Conditions

  • 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:
    • Usual office working conditions.
    • Frequently required to sit; talk; or hear.
    • Frequently use fingers to type and do other fine motor tasks.
    • Occasionally required to stand; walk, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch.
    • Occasionally lift and/or move up to 20 pounds.
    • Specific vision abilities required by this job include close vision, distance vision and depth perception.

Additional Needs/Requirements

  • Must be detailed oriented.
  • Strong ability to multi-task.
  • Must be highly organized.
  • Project management skills desired
  • Excellent verbal, written, and communication skills.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

The Essential Functions and Responsibilities outlined represent typical duties required of the job. The Company will make every effort to reasonably accommodate qualified individuals with disabilities.

Qualified individuals should forward their resume to

popek@hitachihealthcare.com