Regulatory Affairs Specialist

Key Responsibilities

• Prepare, review, and submit regulatory documents for product registrations, renewals, and amendments.
• Support FDA submissions including 510(k), Technical Files, and other regulatory filings as required.
• Ensure compliance with FDA, ISO 13485, MDR, and other applicable medical device regulations.
• Maintain regulatory documentation and product registration records.
• Monitor and interpret changes in regulatory requirements and communicate impacts to internal teams.
• Collaborate with Quality, R&D, Manufacturing, and Clinical teams to support product development and commercialization.
• Auxiliary with audits, inspections, and responses to regulatory authorities.
• Support labelling reviews and regulatory assessments for product changes.

Required Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.
• 2+ years of experience in Regulatory Affairs within the Medical Device industry.
• Knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and global regulatory requirements.
• Experience preparing and managing regulatory submissions.
• Strong documentation, analytical, and organizational skills.
• Excellent written and verbal communication abilities.
• Proficiency with Microsoft Office and regulatory document management systems.