Clinical Pharmacologist

Employer: Biolytical

Location: Richmond, British Columbia

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

bio Lytical is hiring an experienced 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 PMA supplements, 510(k)s, new PM As, Health Canada MD Ls, Notified Body/Competent Authorities. Lead regulatory activities related to product registrations in Rest-of-the-World markets, including but not limited to the WHO and countries in Asia, Africa, and Latin America. This includes creating/revising regulatory submissions in desired formats, facilitating document authentication/