Regulatory Affairs & Quality Assurance Associate

At the service of medical imaging since 1954, Christie Innomed develops, distributes, integrates and supports innovative solutions and products that improve the performance of healthcare institutions in Canada in medical imaging and health IT solutions.

Christie Innomed is today a leader in imaging and medical informatics, with more than 250 specialists serving more than 1,500 hospitals and clinics across Canada.

Job description

> Summary

Reporting to the General Counsel, you will support our manufacturing partners in regulatory applications with Health Canada and help develop and maintain the quality system of Christie Innomed (Medical Imaging) and its Christie Technologies division (Healthcare IT Solutions).

Special projects will be part of your responsibilities as we strive to always improve and aim at developing a continuous improvement mindset and agility to serve the company and our clients better.

> Key responsibilities

  • Health Canada TPD, HPFBI, MHPD
  • ISO Certification 9001, 13485
  • Health & Safety
  • Environmental Regulations
  • Privacy / Confidentiality (HIPPA/PIPA)
  • Ensuring that company‚Äôs products comply with regulations
  • Keeping abreast of legislation, guidelines and customer practices

> Regulatory Affairs

  • Prepare, coordinate and deliver submissions to Health Canada authorities for Class II and III medical devices
  • Promote Christie Innomed’s regulatory services to business partners
  • Implement the processes required to promote and integrate regulatory management into current operations
  • Manage recalls
  • Provide regulatory support to internal and external clients

> Quality assurance Management

  • Ensure company compliance to ISO 9001
  • Manage key quality assurance processes, such as: documents and record control, customer complaints, corrective and preventive actions, non-compliance issues, supplier evaluation, external and internal audits
  • Manage projects related to the improvement of the quality system
  • Carry out internal audits according to established planning
  • Coordinating quality surveys and monitoring
  • Train employees on the importance of quality processes
  • Plan and implement the Quality Communication Plan

Job requirements

> Qualifications and experience

  • University Degree in Science
  • Minimum of 12 years of experience in regulatory affairs and quality assurance, ideally in the Medical Devices sector; a similar experience in the pharmaceutical or biotechnology would be considered
  • Knowledge in the implementation of ISO 13485 MDSAP quality system is an asset
  • Continuous improvement/Lean Six Sigma training (green belt and over) is an asset
  • Fluency in French and English, with strong writing abilities

> Special requirements

  • Strong technical, analytical and organizational skills
  • Ability to manage multiple projects at the same time
  • Excellent communication and interpersonal skills
  • Attention to detail
  • Autonomy and judgment
  • Demonstrated ability to work as part of a team

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