Regulatory Compliance Specialist

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  • Full Time

Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device Associate

Main Purpose of Job and Objectives:

  • Perform Regulatory tasks to ensure compliance with regulations.
  • Prepare regulatory documentation and submissions for product approvals.
  • Develop regulatory plans/strategies for new products and changes to existing products.
  • Participate in Design Control and Risk Management activities.
  • Review and prepare regulatory paperwork in accordance with international standards and regulations.
  • Review product packaging, labelling, IFUs, and marketing literature for compliance.
  • Facilitate compliance with Vigilance System.
  • Provide regulatory input to functional groups.
  • Participate in the review of RA procedures.
  • Review and approve validation protocols and reports.
  • Mentor RA Associates.
  • Facilitate in the compilation, communication, and monitoring of FSN and recalls.
  • Perform other duties as required by the RA department.

Dimensions & Limits of Authority:

  • Must work within the requirements of the company handbook and policy statements.
  • Maintain awareness of the relevance and importance of activities performed and how they contribute to quality objectives.
  • Ensure accurate completion of records and report any quality issues to the immediate supervisor.
  • Ensure facility, processes, and documentation remain in a state of audit readiness.

Qualifications & Experience:

  • Experience in team/project management/custom-made devices is desired.
  • Experience with quality engineering and/or MDR is required.
  • Able to communicate effectively with external parties such as customers and distributors.
  • Able to communicate effectively with personnel in QA/R&D and other departments.

Company Requirements:

  • Must adhere to the company handbook and policy statements.

Quality Requirements:

  • Maintain awareness of how activities contribute to quality objectives.
  • Work within the Quality Management System at all times.
  • Ensure accurate completion of records and report any quality issues to the immediate supervisor.
  • Ensure facility, processes, and documentation remain in a state of audit readiness.

EH&S Requirements:

  • Take care of your own health and safety and that of others who may be affected by your actions.
  • Work cooperatively to highlight issues affecting Health and Safety.
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