Quality Regulatory Specialist

  • Category
    Office, clerical & administrative - Operations
  • Job type
    Temporary/Contract
  • Location
    Markham, Ontario

Adecco is currently hiring for a one-year, temporary Quality & Regulatory Specialist - Medical Devices in Markham. To qualify for this Quality & Regulatory Specialist role, you must have 4-6 years experience in a regulated industry. Salary is $53k-58k / year

 

Why Work for Adecco?

Great pay + 4% vacation pay          

Paid weekly – accurate and on time           

Medical and dental benefits once qualified 

Strong health and safety programs 

Flexible shifts           

Generous referral bonuses

Free training programs        

 

Quality & Regulatory Specialist - Medical Devices Responsibilities:

  • Work with a variety of diverse persons to facilitate reportable device events in accordance with written procedures and global reporting requirements         
  • Prepare and submit Consumer Incident Reports and/or Mandatory Problem Reports to Health Canada as required and maintain all records
  • Determine reportability decision for recalls in Canada and prepare and submit recall report (Health Systems, Personal Health)    
  • Monitor and improve tracking/control systems for medical device reporting         
  • Investigate and prepare responses to address Competent Authority inquiries and provide follow up
  • Manage and execute product field actions and product holds when quality issues are identified.
  • Ensure license is maintained and in good standing with Health Canada
  • Participate in the coordination of external government audits and global quality audits
  • Provide regular reports of quality management system metrics for post market activities
  • Manage radiation servicing notifications
  • Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards
  • Review development quality reports and plans to ensure that the information required for submission is adequate from a non-technical standpoint
  • Plan, generate, and coordinate regulatory submissions for product/solution licensing
  • Coordinate testing required to support regulatory submissions
  • Review and approve product/solution labeling and product/solution-related marketing communication
  • Maintain existing regulatory filings/licenses, managing updates and related change control process
  • If applicable, ensure timely reporting of any post marketing information requests

 

Quality & Regulatory Specialist - Medical Devices Qualifications:

  • Bachelor’s degree in scientific or healthcare-related field  
  • Education in Regulatory/Quality is preferred
  • 4-6 years experience in a regulated industry (Devices, Pharma)
  • Knowledge of the Canadian Medical Device Regulations and Consumer Product Safety Requirements                  

If you are interested in this Quality & Regulatory Specialist - Medical Devices job in Markham, apply by clicking the “Apply now” button below.
B6659

 

 

  • Apply with Adecco

Reference number CA_EN_1_026659_12146381

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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