Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.   

Key Responsibilities 

• Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products 

• Develop and execute regulatory strategies supporting product development and commercialization 

• Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance 

• Interpret FDA guidance related to medical device software and digital health technologies 

• Partner with global regulatory teams to support international regulatory initiatives 

Requireme...