Manager, Management Consulting Service

Employer: Biolytical

Location: Richmond, British Columbia

Salary: $30.00 to $87.00 hourly

bio Lytical is hiring an demonstrated Regulatory Affairs (RA) Associate. You will actively support operations for the market entry of new IVD products and the maintenance of licenses for commercially marketed products. You will share your expertise and help train team members. As a RAC certified professional with US FDA experience, you play a vital role in driving forward our mission to get people tested with the best technology on the market, living the Core Values through and through.HOW YOU WILL CONTRIBUTE Lead the management of regulatory activities involving compliance with government regulations and maintenance of establishment licenses Lead regulatory strategy development and analyze design changes requiring regulatory approval before implementation. Appropriate product classification, preparation of regulatory submissions, and effective negotiation of approvals for device applications from WHO, US FDA, Australia, Health Canada, etc., will be conducted. Perform regulatory activi