Regulatory Compliance Specialist

4 weeks ago

Cambridge, Ontario, Canada Clarion Medical Technologies Inc. Full time

Position Overview:

We are looking for a dedicated individual to join our team at Clarion Medical Technologies Inc. as a Regulatory Compliance Specialist. This role is crucial in ensuring that our quality systems are maintained and continuously improved.

Key Responsibilities:

  • Oversee the ongoing maintenance and enhancement of the organization’s quality management systems, adhering to standards such as ISO 13485:2016, MDSAP (FDA/Canada), and EU (MD).
  • Engage with regulatory bodies to discuss potential compliance pathways, requirements, and to clarify any regulatory submissions that are currently under review.
  • Evaluate and categorize customer complaints according to established criteria, ensuring that all complaints are handled consistently and in compliance with regulatory standards.
    Assign complaints to relevant subject matter experts for those requiring further investigation.
  • Administer the Corrective Actions / Preventative Actions (CAPA) processes for all products, in line with company protocols, including the receipt, investigation, and resolution of product complaints.
  • Manage quarantined inventory and conduct investigations to identify root causes, ensuring compliance with minimal threshold allowances.
  • Lead key initiatives within the quality system, including traceability projects, vendor assessments, temperature monitoring, batch processing, and receiving inspections.

Qualifications:

  • A post-secondary degree or diploma in a relevant scientific field.
  • Experience in an ISO 13485:2016 environment, with a solid understanding of quality system principles.
  • Experience in Post Market Surveillance is considered an asset.
  • Proficient in computer applications, including Microsoft Office Suite (Word, Excel, Outlook).
  • Ability to work autonomously and manage time effectively to meet departmental goals.
  • Demonstrated flexibility and strong organizational skills.
  • A high level of personal integrity and professionalism.
  • Exceptional communication and interpersonal abilities.
  • Strong analytical and problem-solving skills with meticulous attention to detail.

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