Director of Quality Assurance and Regulatory Affairs

1 week ago


Plymouth, United States Interrad Medical Full time

The Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is incompliance with QSR and ISO 13485 requirements as well as country/region specific requirements.

Responsibilities

  • Lead company-wide efforts to maintain and continuously improve the Quality Management System for Interrad Medical to ensure the quality of SecurAcath and other devices and components
  • Oversee QMS training for employees
  • Ensure compliance with the US FDA quality system requirements, EU MDR regulations, ISO 13485 standards, and other applicable regulations and standards across the globe
  • Guide the company’s regulatory strategy
  • Manage regulatory audits and inspections from preparation to responses
  • Includes Medical Device Single Audit Program (MDSAP)
  • Coordinate both internal audits and supplier audits
  • Lead risk management activities from assessment to monitoring
  • Support supplier quality management activities
  • Oversee complaint handling process
  • Support product return and failure analysis
  • Manage corrective and preventive action process
  • Lead post-market surveillance activities including writing and updating PSUR and SSCP reports
  • Oversee document controls including the creation, approval, distribution, and retention of documents as well as the records that are produced
  • Lead quarterly management review meetings for the company
  • Cross-functional collaboration with engineering on product development
  • Cross-functional collaboration with engineering on test methods and with operations on inspection methods
  • Other duties as assigned

Qualifications

  • Bachelors degree in a relevant discipline; master’s degree preferred.
  • Minimum of ten (10) years of experience in both quality and regulatory in medical devices
  • Understands FDA regulations, MDR regulations, ISO standards and other applicable global regulatory requirements and standards
  • Understands current Good Manufacturing Practices (cGMP)
  • Post-market surveillance experience including PSUR and SSCP
  • Experience with QMS software; experience with Grand Avenue software is preferred.
  • Experience managing regulatory audits and inspections
  • ISO 13485 certified internal auditor is preferred


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