The Sr. Regulatory Affairs Specialist will support the programs and processes that ensure that DNA Genotek products comply with applicable global medical device and IVD regulatory requirements for currently engaged and target markets.
- Prepare various regulatory submissions for product approval/registration (i.e., pre-submissions, 510(k), De Novo, PMA, EUA, Health Canada Device License) to support strategic objectives.
- Act as Regulatory lead in new product design and development projects.
- Review and approve complaint assessments to determine per country reportability and impact to current risk assessment.
- Prepare product specific regulatory strategy documents for the project teams and update as the project evolves.
- Evaluate and propose changes to products and controlled documents.
- Assist in review and approval of 510(k) Letter-to-File (Memo to File...