Summary

This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle-from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.

Essential Duties and Responsibilities

• Implement company regulatory affairs procedures.
• Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
• Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
• Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
• Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
• Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
• Support internal and external audits, including FDA inspections and Notified Body assessments.
• Maintain regulatory files and databases, ensuring accurate and up-to-date documentation.
• Participate in post-market surveillance activities, including adverse event reporting and field actions.
• Provide regulatory input during risk assessments and design control processes.

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• 2-5 years of experience in regulatory affairs, preferably in the medical device industry.
• Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
• Experience with regulatory submissions and product registrations in multiple global markets.
• Excellent written and verbal communication skills.
• Strong organizational and project management abilities.

Preferred Qualifications

• RAC certification (Regulatory Affairs Certification).
• Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
• Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.