Regulatory Affairs Associate - Maternity Leave

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

We are seeking a candidate with the following attributes:

• 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

Company Benefits & Perks:

• Life & Health Sciences Sector – making people’s lives better!
• Competitive compensation and benefits plan
• Strong focus on employee engagement and recognition
• Flexible healthcare spending accounts for employee wellness
• Fun culture with high caliber team based across Canada