Regulatory Affairs Analyst

About the Regulatory Affairs Specialist Role

The Regulatory Affairs Specialist is responsible for supporting regulatory compliance, medical device registrations, and quality assurance activities. This position involves preparing and maintaining regulatory documentation, ensuring compliance with FDA and international regulations, and collaborating with internal teams and external stakeholders to meet applicable quality and regulatory standards.

Responsibilities of the Regulatory Affairs Specialist:

• Assist with medical device license registrations and international regulatory submissions
• Prepare, review, and maintain regulatory documentation, including technical files, operating procedures, work instructions, and product labeling
• Ensure compliance with applicable FDA regulations, international requirements, and quality standards
• Support the preparation and maintenance of EU Declarations of Conformity and other required regulatory documentation
• Assist with post-market surveillance and regulatory reporting obligations
• Coordinate regulatory notifications related to product changes, deviations, and change orders
• Support communications with customers, distributors, and regulatory authorities regarding compliance matters
• Prepare and submit supplementary documentation required for international registrations
• Participate in design meetings and provide regulatory guidance
• Assist with internal and external quality audits, including preparation of supporting documentation
• Participate in activities involving customer complaints, recalls, corrective and preventive actions (CAPA), and field corrections
• Attend regulatory and quality meetings, including Quality Steering Team meetings as needed
• Perform other related duties as assigned

Requirements of the Regulatory Affairs Specialist:

• Bachelor's degree in Science, Healthcare, Engineering, Mathematics, Statistics, or a related technical field; or five years of relevant experience or training; or an equivalent combination of education and experience
• At least 2 years of experience in quality assurance or regulatory affairs
• At least 1 year of experience conducting quality audits in a regulated medical company
• Previous Regulatory Affairs or Quality Assurance experience in the medical device industry preferred
• Knowledge of FDA and international regulations and quality standards, including ISO 9001 and ISO 13485, preferred
• Experience communicating with customers preferred
• Proficiency in Microsoft Office programs
• Ability to perform repetitive movements, bend, twist, walk, sit, and handle tools or equipment as required