Quality Specialist (12 Months Contract)

Vantive•Mississauga, ON

2d•Remote

About The Position

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. In this position, you will be responsible for Regulatory Reporting, including final reportability determination or reportability review and/or processing of regulatory reports to Health Canada. This position serves as subject matter expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.

Requirements

Bachelor’s degree in Sciences/Health Sciences or equivalent experience (defined as a minimum of 5 years of medical products industry experience)
1-2 Years working in a regulated industry, preferably in Post Market Surveillance
General knowledge of Quality systems in a GMP environment (Complaints, Regulatory Reports, Documentation, Training)
SOP/Technical Writing experience
Working in IT systems (TrackWise System preferred)
Strong communication and Technical Writing Skills
Strong problem-solving skills and the ability to take the initiative
Self-motivated, self-directed and enthusiastic
Ability to multi-task across many areas
Computer skills (Quality IT systems and Microsoft applications)
Ability to work well and build relationships with internal partners

Nice To Haves

Strong understanding of Health Canada GMPs and Medical Device regulations
Knowledge of renal products and therapies

Responsibilities

Reportability Assessments
Review complaint records to determine reportability according to Health Canada regulations
Ensure reportability assessments are completed in a timely manner
Draft and/or submit Medical Device Problem Reports to Health Canada in a timely manner
Complaint handling activities
Perform daily tasks associated with processing complaint files
Manage a workflow to assist with complaints in progress