Regulatory Affairs and Quality Assurance Associate

•  Help in the creation of regulatory submissions for clinical studies approval and commercial for medical devices with regulators in Canada, USA, Europe and the rest of the world.
• Facilitate regulatory support and guidance to internal and external stakeholders on regulatory requirements.
• Help in the creation and changes of documents that describe the company procedures for activities for all products and in accordance to requirements of ISO 13485,  21CFR820  QMS and other regulatory requirements.
• Contibute to the implementation of training process and tools for employees.
• Responsible for some QA processes such as : customer complaints, change control, corrective and preventive actions, management of non-conforming issues, supplier evaluation and internal audits. Review of stability programs.
• Responsible for document and record control process, custody and archiving of Company documents.

Specific skills and qualifications :

• The candidate should have a university degree in Sciences or related discipline with a least 5 years’ experience in Regulatory Affairs and QA of Medical Devices. Experience in Pharmaceutical or Biotech will also be considered.
• The candidate has played a role in the implementation of QA systems as well as experience in filling regulatory submissions.
• A working knowledge of ISO 13485, QSR, GMP, GCP and GDP processes and regulatory requirements and guidelines is desired.
• Strong analytical, technical and organizational skills, able to handle multiple projects, as well as interpersonal and communications skills are imperative for this position.
• Experience in Dermatology and Wound Care an asset.

Must be bilingual English - French