Regulatory Affairs Specialist

Responsibilities:

Assist with strategy, planning, preparation and submission of medical device license/ registration applications to Health Canada, FDA, and rest of the world countries

Work closely with the supervisor, local regulatory representatives, and distributors to compile regulatory submissions and efficiently respond to review queries from global regulatory agencies.

Maintain and update registrations and licenses as required. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, notification of changes and annual updates

Ensure accurate and timely submissions to regulatory agencies

Maintain current knowledge of international regulations, guidance and standards applicable to our client's products and ensure compliance

Research regulatory issues and disseminate regulatory information to Production, QA/QC, and R&D departments and senior management