Regulatory Affairs Specialist

About the role

This position is responsible for preparing submissions to various regulatory agencies and helping maintain and improve domestic and international compliance. The candidate must work well in a team environment and demonstrate great attention to detail.

Responsibilities

• Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives.
• Prepare, maintain, and submit European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
• Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Work with the international department on various regulatory filings for product registration in different countries.
• Provide regulatory support for other projects as required.
• Update appropriate personnel on new and revised processes and procedures.
• Process, execute, organize, and archive various internal documentation related to Engineering and/or Quality Systems.
• Prepare change order documentation and route it for final approval.

Requirements

• Minimum of 2-year college degree; Bachelor’s Degree (or greater) preferred.
• Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
• Previous experience creating and revising labels and DFUs preferred.
• Knowledge of European, ISO 13485, and FDA regulations preferred.
• Knowledge of international regulatory guidelines regarding GMP requirements is desirable.

Skills

• Ability to communicate across functions, professional levels, and backgrounds.
• Intermediate to advanced knowledge of Microsoft Office Suite.
• Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.
• Effective communication for complex situations, analysis of numbers, and interpretation of written materials.
• Troubleshoot and solve problems while maintaining positive working relationships.

Essential Job Functions

Mental

• Communicate effectively with others.
• Complete and understand complex situations and numerical analysis.
• Read, analyze, and interpret written materials.
• Work with a team to meet and exceed company standards.
• Ensure compliance with company policies and respond to feedback for improvements.

Physical

• Communicate for extended periods.
• Use computer equipment for prolonged durations.
• Work in moderate noise levels with limited exposure to physical risk.

Special Requirements

Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.