FDA Regulatory Specialist Job Description Template

The FDA regulatory specialist focuses specifically on United States market access, covering premarket submissions, agency interaction and the post market obligations that follow. The role requires detailed knowledge of the relevant regulations and guidance documents, and the judgment to know when a device modification crosses the line that triggers a new submission.

Typical Duties and Responsibilities

• Prepare and manage FDA premarket submissions including 510(k) and De Novo
• Identify appropriate predicate devices and build substantial equivalence arguments
• Manage pre submission meetings and agency correspondence
• Respond to additional information requests within required timeframes
• Assess device changes against the letter to file threshold
• Maintain establishment registration and device listing
• Manage medical device reporting and recall obligations
• Interpret FDA guidance documents and apply them to the portfolio
• Support inspection readiness and respond to observations
• Advise product teams on FDA implications during development

Education

• Bachelor’s degree in engineering, life sciences or a related field

Required Skills and Experience

• 4+ years of FDA regulatory experience in medical devices
• Track record of successful 510(k) or De Novo submissions
• Detailed knowledge of 21 CFR Parts 803, 806, 807 and 820
• Experience with pre submission meetings and agency interaction
• Sound judgment on change significance assessments
• Excellent regulatory writing
• Understanding of clinical and bench evidence requirements
• Experience supporting FDA inspections

Preferred Qualifications

• Experience with Class III or PMA products
• Software as a medical device submission experience