Company: NES Fircroft
Skills: Regulatory Compliance
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Salary: Competitive
Location: Oakville, Ontario, Canada


Our client is currently seeking a Regulatory Affairs Professional for a long-term contract based out of Ontario.

 

Key Responsibilities

  • Support regulatory affairs submissions activities for Health Canada Class II-IV in vitro?diagnostics (IVD) medical devices for commercialization in Canada.
 

  • Identify, analyze the requirements, and prepare product related regulatory submissions to Health Canada.
 

  • Interact with internal organizations (e.g. Business Lines) to plan and prepare product related regulatory activities.
 

  • Submit required product related regulatory documentation/information to Health Canada.
 

  • Initiate and escalate necessary activities if deviations are identified.
 

  • Ensure creation of adequate documentation for audits/inspections, including updating of electronic department files.
 

  • Contribute to the regulatory affairs team effort, awareness of expected responsibilities and value-add.
 

  • Carry out duties in compliance with established business policies.
 

  • Perform other duties and projects as assigned.
 

Qualifications:

This position requires the ideal candidate to possess effective oral and written communication, time management, project planning and organizational skills. S/he must also demonstrate proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives to meet rigorous deadlines with minimal supervision.

 

Additionally, the following qualifications and experience must be met:

  • Solid working knowledge of Health Canada Medical Devices Regulations and associated guidance documents.
 

  • Must have experience in medical device submissions to Health Canada (IVD experience - preferred).
 

  • BSc or higher (Science or Engineering preferred).
 

  • Should possess or be working towards a Regulatory Affairs post-graduate degree diploma or certificate.
 

  • Candidate must be Fully Vaccinated**
The worker must bring evidence of full vaccination to the job site. The worker can present the print vaccination certificate, download one from the Public Health tool, or present the QR code applicable in his province of residence.

**Fully Vaccinated means a state of being 14 days after receiving the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (i.e. two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series), and which may include, at companies discretion, any additional doses (i.e. booster shots) if and when such additional doses are approved by Health Canada and the applicable provincial health authority.

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.