As a major contributor to the Regulatory Affairs team in a growing Diagnostic Development and Manufacturing company, you will have primary responsibility for ensuring compliance with the regulatory requirements necessary to register and market our IVD products globally. In this role, you will interface with regulatory agencies, prepare submission documents, and work cross functionally to provide compliance guidance.
Advise internal stakeholders (marketing, manufacturing, r&d, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. To ensure regulatory strategy is in alignment with company objectives.
In this role, you will generate and review regulatory submissions ( 510(k), PMA, IDE, License Applications, etc. ) to obtain FDA and Health Canada clearance / approval to commercially distribute products.