Regulatory Affairs Specialist

A Regulatory Affairs Specialist supports the implementation of comprehensive regulatory strategies for limited-scope medical device projects, ensuring alignment with company objectives and compliance with relevant regulations. The role involves collaborating with cross-functional teams to manage regulatory filings, licenses, and conformity assessments while maintaining adherence to established operational policies and procedures. Responsibilities include coordinating product/solution licensing submissions, reviewing labeling communications, and staying abreast of evolving regulatory agency changes.