Regulatory Affairs Specialist

CorDx•Alpharetta, GA

40d

About The Position

The Regulatory Affairs Specialist will support the preparation, review, and submission of regulatory documentation for medical device/IVDs products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position focus on submitted documents preparing, helping to secure timely product approvals and regulatory clearances.

Requirements

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required
2-3 years of regulatory affairs experience within the medical device or IVD industry
Working knowledge of 510(k) submissions and regulatory documentation processes
Solid understanding of FDA regulations and Guidance. (510k, PMA, De novo)
Strong organizational and project management skills with the ability to manage multiple projects and priorities
Excellent communication, problem-solving, and attention to detail
Ability to work collaboratively in cross-functional teams and manage document workflows

Nice To Haves

Mandarin Preferred
Experience interacting with FDA and other regulatory agencies preferred

Responsibilities

Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies
Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards
Working on analytical performance test with product development teams to draft documentation.
Perform regulatory assessments for product changes and propose appropriate regulatory pathways
Maintain documentation and records of all regulatory submissions and correspondence
Support the preparation for regulatory agency meetings, audits, and inspections