Compliance Specialist

5 months ago

Barrie, Canada Southmedic Inc. Full time

**REPORTS TO**: Quality Assurance & Compliance Manager

**JOB SUMMARY**

The Compliance Specialist is responsible for supporting the maintenance and overall health of the Southmedic Quality Management System by providing compliance support to Engineering, Document Control and Regulatory Affairs. The Compliance Specialist will also support in the execution of regulatory activities to support Southmedic’s proprietary medical devices.

**KEY DUTIES**
- Involved in all regulatory activities associated with the Tier1 Proprietary Products, to ensure compliance with the regulatory requirements of Canada (Health Canada), US (FDA), Europe (MDD), and other international opportunities.
- Support and champion the Quality Policy Manual (QPM) and the Quality Management System (QMS) through the maintenance and establishment of electronically controlled documents through the uniPoint software.
- Identify areas of opportunities within the Quality Management System (QMS) to support Southmedic’s key business objectives through the initiation of Corrective and Preventive Actions when appropriate.
- Take ownership of projects and work independently within a team environment to reach departmental and company goals.
- Communicate clearly, effectively, and professionally with customers, registrars, regulatory representatives, suppliers and within the Southmedic team.
- Lead internal audit program
- Manage Restricted Substances program.
- Key support to External, Customer and Regulatory audits.
- Conduct and schedule supplier audits.
- All other projects and duties as assigned.

**EDUCATION/EXPERIENCE/SKILLS**
- Bachelor of Science or Engineering, or post-graduate education in a Quality Assurance or Regulatory discipline
- Experience working within a Quality Management System including ISO 9001, ISO 13485, and within a regulated manufacturing environment
- Experience in regulatory affairs, customer service, root cause analysis, meeting management, time management, and technical writing
- Strong background in GMPs, EU MDD/MDR, MDSAP and FDA Part 820 requirements would be considered an asset.
- Experience or training in auditing, would be considered an asset.

Southmedic is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please advise the Human Resources Department.

SM

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