Regulatory Affairs Associate

3 weeks ago

Cambridge, Canada Clarion Medical Technologies Inc. Full time

The successful applicant will:

- Responsible for the maintenance and continual improvement of the company’s quality systems (ISO 13485:2016, MDSAP (FDA/Canada), EU (MD).
- Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, or clarification and follow-up of regulatory filings or submissions under review.
- Review, triage and confirm complaints as per defined criteria, ensuring customer complaints are received and processed appropriately and consistently to meet regulatory requirements
- Manage the Corrective Actions / Preventative Actions processes for all products in accordance with established company procedures including receiving, investigating and closing product complaints
- Manage Quarantined inventory and investigating root origins to meet mínimal threshold allowances
- Complete key projects within the quality system such as traceability, vendor reviews, temperature monitoring, batch work processing and receiving inspections
- Post-secondary degree/diploma (Sciences)
- Experience working in an ISO 13485:2016 environment, as well as a good understanding of quality system principles
- Ability to work independently
- Flexible and strong organizational skills to manage time and productivity level to meet department metrics
- High level of personal integrity is required
- Excellent communication and interpersonal skills
- Strong problem solving skills and attention to details

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