Global Regulatory Affairs Specialist

Applied Medical Technology, Inc.; Brecksville (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Applied Medical Technology, Inc. in Ohio seeks a Regulatory Affairs Specialist to manage submissions to regulatory agencies and ensure ongoing compliance for domestic and international markets.

You will collaborate with the Regulatory team and various departments to prepare FDA 510(k) submissions, EU Technical Files, and maintain up-to-date documentation.

The role requires attention to detail, strong communication, and knowledge of ISO 13485 and GMP requirements.

Qualifications

• Minimum of 2-year college degree required; Bachelor’s preferred.
• Experience in medical or regulated industry is desirable.
• Knowledge of ISO 13485 and FDA regulations is desirable.
• Experience creating and revising labels and DFUs preferred.

Responsibilities

• Prepare and submit regulatory documentation to FDA, Notified Bodies, and other regulatory authorities.
• Prepare and maintain European Technical Files for MDR/IVDD compliance.
• Create and modify regulatory procedures to stay compliant with FDA, ISO, European and Canadian standards.
• Coordinate regulatory filings for product registrations with international teams.
• Provide regulatory support for other projects and update personnel on changes.

Skills

Communication across functions

Microsoft Office

Prioritization and independence

Education

2-year college degree

Bachelor’s degree or higher preferred

Tools

Microsoft Office Suite

Job description

Applied Medical Technology, Inc. in Ohio seeks a Regulatory Affairs Specialist to manage submissions to regulatory agencies and ensure ongoing compliance for domestic and international markets.

You will collaborate with the Regulatory team and various departments to prepare FDA 510(k) submissions, EU Technical Files, and maintain up-to-date documentation.

The role requires attention to detail, strong communication, and knowledge of ISO 13485 and GMP requirements.