Regulatory Affairs Associate - Maternity Leave

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
Assign complaints to the appropriate subject matter experts for filed complaints that may require further investigation
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 minimal 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
Post Market Surveillance experience is an asset
Computer literacy – including Outlook and Microsoft applications such as Word and Excel.
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

Method of Application: hr@clarionmedical.com Clarion is an equal-opportunity employer