Senior Quality & Regulatory Manager, Medical Devices

Bryan Medical; Cincinnati (OH); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Generous compensation package

Health and dental benefits

Paid time off and company-paid holidays

Job summary

Bryan Medical, based in Cincinnati, is seeking a full-time Quality and Regulatory Affairs Manager to oversee compliance with regulatory standards and manage quality control processes. The ideal candidate will have a Bachelor’s degree and proven experience with FDA 510(k) applications.

This hybrid role offers a competitive compensation package and benefits including health, dental, and paid time off. Join a growing medical device company with an international presence, where you can directly impact patient safety and operational excellence.

Qualifications

• Proven experience in preparing FDA 510(k) applications.
• Strong knowledge of ISO 13485 processes.
• Hands-on experience in medical device manufacturing quality.

Responsibilities

• Prepare and submit FDA 510(k) applications.
• Manage regulatory inquiries and documentation.
• Maintain and improve the Quality Management System.

Skills

FDA 510(k) applications

ISO 13485 knowledge

Document control

Quality management

Regulatory compliance

Education

Bachelor’s degree in a relevant field

Tools

eQMS systems

CAPA

Job description

Bryan Medical, based in Cincinnati, is seeking a full-time Quality and Regulatory Affairs Manager to oversee compliance with regulatory standards and manage quality control processes. The ideal candidate will have a Bachelor’s degree and proven experience with FDA 510(k) applications.

This hybrid role offers a competitive compensation package and benefits including health, dental, and paid time off. Join a growing medical device company with an international presence, where you can directly impact patient safety and operational excellence.