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.

Your Role:

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.

What you'll be doing:

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

What you'll bring:

• Bachelor’s degree in Sciences/Health Sciencesor 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 have:

• Strong understanding of Health Canada GMPs and Medical Device regulations

• Knowledge of renal products and therapies

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $49,000 to $70,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Existing Position: Yes — this role is a temporary position to cover a maternity leave.

Work Setup: Remote/Hybrid

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

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