Regulatory Affairs Specialist

Job Description:
We are looking for a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist provides leadership and input on company strategies and programs involving regulatory and government agencies; helps to develop strategies to ensure regulatory requirements are met; determines requirements, then compiles and files applications for sale of Innovasis products with regulatory and government agencies; provides regulatory input to project teams; plans and implements policies, procedures, practices, and strategies for Regulatory Affairs. The position provides backup for interfacing with regulatory bodies and/or Auditing Organization(s).

Responsibilities:

Assists in developing the company's quality management system in compliance with all relevant standards and regulations.

Prepares appropriate technical, quality, manufacturing, and regulatory data and documentation for the purpose of supporting QMS certif...