Regulatory Affairs Specialist, Medical Devices and Software

Job overview

The Regulatory Affairs Specialist role is onsite in Wooster, OH, and compensation is not specified. PRC-Saltillo’s mission is to empower individuals through innovative communication solutions. The specialist manages regulatory submissions and product documentation and advises teams on compliance across product development, manufacturing, labeling, marketing, and distribution. The role helps ensure medical devices and software products meet requirements in domestic and international markets.

What you'll do

• Manage regulatory submissions, registrations, renewals, and documentation
• provide regulatory guidance across product activities
• maintain technical documentation and regulatory files
• review product changes, labeling, and marketing materials
• monitor regulatory changes and recommend process improvements
• represent Regulatory Affairs on project teams
• support risk assessments, recalls, medical device reporting, and audits as needed.

What we're looking for

Skills & competencies

regulatory affairs

medical devices

software compliance

product registrations

regulatory submissions

quality systems

regulatory audits

global markets

wooster oh

prc-saltillo

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a related field and at least five years of regulatory affairs experience in a regulated environment.

About the employer

PRC-Saltillo is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.