Regulatory Affairs Specialist

  • Location
    Ottawa, Ontario
  • Job type
  • Category
    Professional & executive - Executive

Adecco is currently hiring for a Regulatory Affairs Specialist for our Medical Device Manufacturing client in Ottawa West. This is a 1 year contract opportunity offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. Our client is able to provide sufficient time for relocation to Ottawa.

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system.  

Regulatory Affairs Specialist Responsibilities:

  • Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
  • Communicates issues to management through project management tracking and issue briefings.
  • Position is highly visible to internal and external stakeholders.
  • Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
  • Responsible for effective communication of regulatory requirements to project teams and internal customers.”
  • Regulatory Affairs Specialist Requirements:

  • Bachelor's degree required, Masters degree preferred
  • Bachelor in Life Science or Biology is preferred
  • Minimum of 5 years of Regulatory Affairs experience
  • Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)
  • Knowledge and experience with In Vitro Diagnostic Devices IVDs
  • Knowledge and experience with FDA 510K submission, Health Canada Application, and EU Tech File preparation and submission under IVDD and IVDR
  • knowledge of IVDD and IVDR (EU Directive and Regulation) is an asset
  • Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
  • Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
  • Ability to manage and track broad and strategic projects.
  • Ability to communicate effectively in writing crisp briefings and issue analysis. Demonstrated ability to work effectively in a team environment.
  • High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.              
  • To be considered for this Regulatory Affairs Specialist opportunity, please Apply Now!



    • Apply with Adecco

    Reference number CA_EN_1_021956_1580573

    Accommodation will be provided in all parts of the hiring process as required under Adecco’s Employment Accommodation policy. Applicants will need to make their needs known in advance to their Adecco representative.

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