Global Regulatory Affairs Specialist — Submissions & Compliance

Comunidade Metodista; Brecksville (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

CEDENT is seeking a Regulatory Affairs Specialist in Brecksville, OH to prepare regulatory submissions and maintain compliance for medical devices. You will coordinate with FDA, Notified Bodies, and international partners to ensure timely registrations and documentation updates.

The role requires knowledge of FDA/ISO requirements, experience with regulatory filings, and strong attention to detail. A bachelor’s degree and relevant experience are preferred.

Qualifications

• Bachelor’s degree or higher preferred.
• 2+ years in a medical/regulatory environment.
• Experience creating/revising labels and DFUs preferred.
• Knowledge of European regulations, ISO 13485 and FDA regulations preferred.
• Knowledge of GMP guidelines desirable.

Responsibilities

• Prepare and submit regulatory documentation (e.g., FDA 510(k)) to FDA, Notified Bodies, and Authorized Representatives.
• Prepare and submit European Medical Device Directive/Regulation compliant Technical Files.
• Create or modify regulatory procedures to stay compliant with FDA, ISO, European, Canadian standards.
• Coordinate regulatory filings for product registrations in different countries with the international department.
• Provide regulatory support for other projects as required.
• Update personnel on new and revised processes and procedures.
• Process, organize, and archive internal docs related to Engineering/Quality Systems.
• Prepare change order documentation and route for final approval.

Skills

Regulatory knowledge

Attention to detail

Cross-functional communication

Team collaboration

Education

Bachelor’s degree or higher

Experience in medical/regulatory field

Experience with labels/DFUs

Knowledge of ISO 13485 & FDA

GMP knowledge

Tools

Microsoft Office

Documentation management

Job description

CEDENT is seeking a Regulatory Affairs Specialist in Brecksville, OH to prepare regulatory submissions and maintain compliance for medical devices. You will coordinate with FDA, Notified Bodies, and international partners to ensure timely registrations and documentation updates.

The role requires knowledge of FDA/ISO requirements, experience with regulatory filings, and strong attention to detail. A bachelor’s degree and relevant experience are preferred.