Quality Control Regulatory Affairs Compliance Co-ordinator
Our client designs, develops and manufactures laser equipment for cancer treatment and therapeutic uses. The client is certified to ISO 13485. They are seeking a productive, experienced RA Compliance Co-ordinator who is creative and has excellent problem solving abilities.
Responsibilities will include:
- Meet regulatory requirements and compliance with FDA, EU MDDs, preparations, submissions, and post market
- Update the QMS and lead the transition to the ISO 13485:2016 MDSAP standard
- Ensure the company is fully compliant with ISO 13485:2016, Medical Device Directives,
Canadian Medical Device Regulations and FDA CDRH.
- Prepare regulatory submissions for FDA, CE Mark, Health Canada approvals
- Prepare for internal audits and inspections and lead ISO audits and FDA inspections
- Prepare for quarterly CSA audits and interface with CSA auditors.
- Responsible for the review, control and release of documentation and records in support of the
quality management system including maintaining the design history file, device history records
and device master records.
- Develop quality metrics and provide analysis to support continuous improvement of product and
- Own the CAPA process and implementation of corrective action both internally and as required
- Support Production as needed when Quality duties are light.
- 5+ years’ experience in a Quality Assurance / Regulatory role in a Medical Device Manufacturing
facility under ISO 13485
- Record of successful regulatory submissions to the FDA, Health Canada, and CE mark
- Experience leading internal audits, ISO audits, and FDA inspections.
- Experience in Risk Management – ISO 14971
- Willingness to work with production when things are slow in Quality/Regulatory
NICE TO HAVE:
• Certified Quality Engineer Certificate
Job Type: Full-time position, reporting to the V.P. of Engineering
Job Location: Toronto, ON
Required education: Regulatory Affairs Certificate