- Ensures clear communication of project activities in a timely manner.
- Ensures submissions are completed, properly formatted and comply with applicable regulatory requirements and the company’s processes.
- Preparation of responses to clarification requests according to Health Canada’s deadlines
- Ensures timely and appropriate regulatory submission management for Medical Device License (MDL), Drug Establishment License (DEL), Medical Device Establishment License (MDEL), Drug Applications (including DINs NDSs, ANDSs) and associated annual renewals.
- Assess regulatory reporting requirements for new products and post approval product changes.
- Contribute to strategies to resolve potential regulatory issues.
- Contribute to the company’s expertise in Canadian Health Authority Guidance and Requirements.
- Ensures liaison with Health Canada for general regulatory matters and product-specific issues, including meetings and negotiations with the Agency.
- The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.
To apply for this job please visit www.brunel.energy.