Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

The Sr. Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies.

• Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product.
• Responsible for preparing Canadian applications to obtain approval to commercially distribute product.
• Review and approve test protocols/reports and other documentation/information for regulatory submissions ...