Quality Assurance and Regulatory Specialist

Full Time
GTA, Toronto
Posted 4 weeks ago

Future Fertility is a Canadian start-up located in Toronto. We develop and market AI-enhanced software solutions in the high-growth market of Assisted Reproductive Technology (ART). We have been chosen by MaRS, North America’s largest urban innovation hub, to be showcased as one of their portfolio companies. We are trusted by some of the best IVF clinics in North America and Europe and have successfully raised a Series A financing round. The investment was led by M Ventures (the corporate venture capital arm of Merck KGaA, Darmstadt, Germany, a global fertility leader), with participation from Whitecap Venture Partners. 

Insights yielded by this patented software technology will be invaluable to patients, clinicians, and researchers. To learn more, please visit: https://futurefertility.com/ . 

Following recent positive news, Future Fertility is now embarking on a substantial organizational scale-up to support a number of corporate development objectives. FF is seeking an Quality Assurance and Regulatory Specialist who will enjoy supporting our dynamic, multidisciplinary team in the #femtech space and is self-motivated. S/he is a ‘go to’ person and is skilled at identifying a problem, offering best possible solutions and driving issues to closure. This is a hybrid role, due to the level of collaboration required between various functional groups and stakeholders.

Responsibilities

  • Testing/technical evaluation of product features and improvements, help to prioritize development; address critical issues quickly, providing adequate support to ensure issues are resolved
  • Organize effective QA workflows with development and product teams, taking ownership of product quality; Refine FF’s QA processes and provide and maintain QA documentation
  • Serve as the go to person for regulatory matters (related to Health Canada, Food and Drug Administration); Coordinate compliance documentation; Maintain awareness of standards that regulate our industry; Communicate with external regulatory consultants
  • research funding and grant opportunities; coordinate the grant application submission process
  • Investigate competition (i.e. market intelligence) and other developments, research publications
  • Write and contribute to abstracts and other (scientific) publications
  • Document preparation, information management, file maintenance, and coordination of regulatory related tasks across multiple departments
  • Work cross functionally to drive results and be flexible to meet the needs of a growing company
  • Provides regular reporting within specified deadlines

Qualifications

  • At minimum a completion of a Bachelor’s degree program in the health tech or similar technical/scientific field is required
  • Must understand all aspects of product development, including research, clinical trials, regulations, and approval processes
  • Demonstrated technical competency and working technical knowledge and application of QA & RA concepts, practices and procedures
  • Proven ability to test against business and technical requirements, develop test cases, produce descriptive, reproducible defect reports and track overall progress toward deliverables.
  • Excellent Team player with strong interpersonal skills; ability to effectively work with colleagues on all levels and functions in a fast-paced, short-timeline, detail-oriented environment.
  • Fast learner, creative problem solver, client centric
  • Ability to work under pressure; Biased toward action
  • Strong problem-solving and relationship building skills
  • Excellent organizational and time management skills
  • Ability and willingness to work on a hybrid basis to FF’s Toronto office

Full vaccination for COVID is a requirement for this position. Applicants may request a reasonable accommodation based on disability and/or religion reasons. FF reserves the right to deny such requests when appropriate.

Job Features

Job CategoryQuality Assurance
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