Regulatory Affairs Specialist Job Description Template

The regulatory affairs specialist gets devices approved and keeps them compliant across the markets where they are sold. The work covers submission strategy, technical documentation, interaction with regulators and the ongoing obligations that follow clearance. Getting the strategy right early is worth a great deal, because a poorly chosen regulatory pathway can add a year to a launch.

Typical Duties and Responsibilities

• Determine the appropriate regulatory pathway for new and modified devices
• Prepare and submit regulatory filings such as 510(k) or technical files
• Compile technical documentation from engineering and clinical inputs
• Respond to regulator questions and information requests
• Assess whether a proposed change requires a new submission
• Maintain registrations, listings and market authorisations
• Monitor evolving regulation and assess its impact on the portfolio
• Support labeling review and promotional material compliance
• Manage post market reporting obligations including adverse events
• Advise product teams on regulatory implications early in design

Education

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

Required Skills and Experience

• 3+ years in medical device regulatory affairs
• Experience preparing submissions such as 510(k), De Novo or CE technical files
• Knowledge of FDA regulation and EU MDR requirements
• Ability to assess change significance against regulatory thresholds
• Strong technical writing
• Experience interacting with regulators or notified bodies
• Understanding of clinical evidence requirements
• Ability to advise engineering teams practically

Preferred Qualifications

• Regulatory affairs certification
• Experience with software as a medical device submissions