Quality & Regulatory Manager

3 weeks ago

Louisville, United States MAGNA WAVE Inc Full time $80,000 - $120,000
Job DescriptionJob Description

The Quality & Regulatory Manager owns, audits, and drives improvements within the MagnaWave Quality Management System (QMS). The Quality and Regulatory Manager will manage the organizations’ registrations, applications, readiness to enter new markets (domestic and international), and the company’s compliance with standards and requirements in all markets.

Job Responsibilities:

  • Develop regulatory strategies
  • Serve as official FDA correspondent
  • Host all FDA and regulatory agencies audits, complete annual registrations
  • Assess need for regulatory registrations
  • Manage all quality procedures & supporting documentation
  • Responsible for the Document control process and the efficient control of all documentation required by regulatory agencies; provide recommendations for continuous improvement of document change control and document retention.
  • Audit all quality procedures & supporting documentation as scheduled to ensure compliance
  • Conduct internal reviews/audits to ensure the QMS is being implemented appropriately
  • Manage corrective and preventative action procedures
  • Conduct ongoing company-wide training on FDA and ISO requirements.
  • Verify that all quality and regulatory policies and procedures have been documented, implemented, and communicated
  • Manage the complaint handling process and nonconforming material process
  • Manage supplier qualification activities and monitor performance
  • Remain educated and up-to-date on regulations

Education and Experience:

  • High School Diploma required; college degree preferred
  • Certification in Quality or Regulatory Systems preferred; FDA and ISO 23485 experience helpful
  • Knowledge and experience in technical writing and/or government submissions
  • Project management experience preferred
  • Knowledge of Core platform or similar documentation software/programs
  • Excellent verbal and written communication skills, able to communicate effectively with all levels within the organizations

Physical Demands:

  • May be frequently required to sit or stand for periods of time
  • May be required to push, pull, or lift objects up to 50 lbs.
  • Ability to travel (domestic and international) as company grows (

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