Regulatory Affairs Engineer

Position Overview

We are seeking a detail-oriented and experienced Regulatory Affairs Engineer to support regulatory strategy and compliance for Class II medical devices. This role will ensure adherence to FDA requirements and international quality standards, including ISO 13485, IEC 60601, and ISO 14971.

The ideal candidate has strong experience in FDA submissions, risk management, and quality system compliance within the medical device industry.

Key Responsibilities

· Prepare and submit FDA 510(k) submissions and regulatory documentation for Class II devices

· Help define regulatory strategy and pathways for new and existing products

· Maintain and support compliance with:

o 21 CFR Part 820 Quality System Regulation

o ISO 13485 – Quality Management Systems

o IEC 60601 – Medical Electrical Equipment Safety

o ISO 14971 – Risk Management for Medical Devices

Develop and maintain:

o Design History Files (DHF)

o Technical Documentation and product files

o Risk Management Files and usability documentation

· Support internal and external audits and inspections

· Interface with FDA and other regulatory bodies as needed

· Review engineering changes for regulatory impact

· Provide regulatory guidance during product development lifecycle

Qualifications

· Bachelor’s degree in Engineering, Regulatory Affairs, Biomedical Engineering, or related field

· 3+ years of regulatory experience in medical devices

· Experience preparing and submitting FDA 510(k) documentation

· Strong understanding of:

o 21 CFR Part 820

o ISO 13485

o ISO 14971

o IEC 60601

· Knowledge of risk analysis methods (FMEA, hazard analysis)

· Excellent documentation and communication skills

Preferred Qualifications

· RAC (Regulatory Affairs Certification) preferred

· Experience with medical electrical devices

· Experience working medical device environments

Pay: Up to $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person