Specialist Doctor

Employer: Biolytical

Location: Richmond, British Columbia

Salary: $99,727.00 to $535,765.00 annually

bio Lytical is hiring a Senior Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to obtaining approvals for new or modified products and maintaining existing product registrations to meet bio Lytical's corporate objectives. You will 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 Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body, WHO. These include but not limited PMA supplements, 510(k)s, new PM As, Health Canada MD Ls, Notified Body/Competent Authorities. Lead regulatory activities related to Pre-market approvals or product clearance in the USA from the FDA and inspections when necessary. Create technical files in accordance with European IVDR 2017/746 and maintain working relationships with Notified Body during reviews and audit