The Regulatory Affairs Lead is responsible regulatory filings to bring products developed by Zilia
to market in several countries.
Duties and responsibilities
- Author documents and support preparation of regulatory submissions.
- Author, develop through collaboration, and help implement documents that are part of the quality management system, such as SOPs, Work Instructions, Forms and other documents.
- Prepare regulatory reports including those related to problems with medical devices, annual
surveillance reports and other reports as well as manage recalls.
- Review and advise on product labelling, including instructions for use, to ensure compliance with applicable regulations and standards.
- Assess regulatory impact of changes associated with product design change and control of routine changes.
- Review technical protocols and data to support clinical trials, validation, verification, and product manufacturing.
For this position it is necessary to have an intermediate understanding of medical devices and their use, as well as understanding of the regulatory and quality assurance processes.
- Bachelor’s degree in life sciences, technical/engineering, or a related field.
- 4-6 years of experience in Regulatory Affairs, Engineering, Quality, or related field – a
combination of education and experience can be considered.
- Excellent communication skills; written and oral in French and English.
- Good skills with Microsoft Office Suite.
- Ability to read, understand and interpret, FDA, EU and Health Canada medical device regulations and requirements.
- Knowledge of ISO 13485 and MDSAP is an asset.
- Regulatory Affairs and Internal Auditor Certifications are an asset.
- Experience with clinical trials is an asset.
- Strong attention to detail is required, as well as ability to multi-task and designate priorities.
- Ability to keep updated with regulations pertinent to the company’s activities.