Regulatory Affairs Associate - Cambridge, Canada - Clarion Medical Technologies Inc.

Clarion Medical Technologies Inc.

Verified Company

Cambridge, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

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 followup 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
Postsecondary 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