Global Regulatory Submissions Specialist

Applied Medical Technology, Inc. (AMT); Brecksville (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Applied Medical Technology, Inc. (AMT) seeks a Regulatory Affairs Specialist in Ohio to prepare regulatory submissions and maintain compliance across domestic and international markets.

The role reports to the Director of Regulatory Affairs and requires meticulous attention to detail, teamwork, and knowledge of FDA, ISO 13485, and GMP requirements. Prior experience with medical devices is preferred.

Qualifications

• Ability to prepare regulatory submissions and maintain compliance across domestic and international markets.
• Knowledge of FDA, ISO 13485, and GMP requirements is desirable.
• Experience with medical device regulations and regulatory documentation.

Responsibilities

• Prepare and submit regulatory documentation to FDA, Notified Bodies, and Authorized Representatives.
• Develop and maintain regulatory files for EMD Directive/ MDR where applicable.
• Create and update regulatory procedures to stay compliant with global standards.
• Coordinate with international teams on product registrations in different countries.
• Provide regulatory support for projects and update stakeholders on new processes.

Skills

Regulatory submissions

FDA compliance

ISO 13485

GMP knowledge

Documentation

Education

2-year college degree

Bachelor's degree preferred

Job description

Applied Medical Technology, Inc. (AMT) seeks a Regulatory Affairs Specialist in Ohio to prepare regulatory submissions and maintain compliance across domestic and international markets.

The role reports to the Director of Regulatory Affairs and requires meticulous attention to detail, teamwork, and knowledge of FDA, ISO 13485, and GMP requirements. Prior experience with medical devices is preferred.