Global Regulatory Affairs Specialist – Medical Devices

Prentke Romich Company; Wooster (OH); Sur place; USD 55 000 - 90 000; Plein temps

Résumé du poste

PRC-Saltillo is seeking a Regulatory Affairs Specialist to ensure our medical devices and software meet regulatory requirements across the U.S., Canada, Europe, and global markets. You will collaborate with engineering, quality, and product teams to manage submissions and maintain regulatory files.

The role requires 5+ years of regulatory experience, strong analytical and communication skills, and the ability to navigate diverse regulatory landscapes.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum five years of regulatory affairs experience in a regulated environment.
• Proficiency with Word, Excel, and PowerPoint.

Responsabilités

• Manage regulatory submissions, registrations, renewals, and related documentation for domestic and international markets.
• Provide regulatory guidance for development, manufacturing, labeling, and marketing activities.
• Create and maintain regulatory files, Declarations of Conformity, and technical documentation.
• Review changes and materials to ensure compliance with applicable regulations.
• Monitor regulatory changes and recommend process improvements.
• Represent Regulatory Affairs on project teams and provide expertise.
• Support regulatory audits, recalls, and reporting activities.

Connaissances

Regulatory research

Regulatory compliance

Communication skills

Analytical thinking

Audit participation

Stakeholder collaboration

Multitasking

Organizational skills

Problem solving

5+ years regulatory experience

Formation

Bachelor’s Degree in Life Sciences/Engineering/Business

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

PRC-Saltillo is seeking a Regulatory Affairs Specialist to ensure our medical devices and software meet regulatory requirements across the U.S., Canada, Europe, and global markets. You will collaborate with engineering, quality, and product teams to manage submissions and maintain regulatory files.

The role requires 5+ years of regulatory experience, strong analytical and communication skills, and the ability to navigate diverse regulatory landscapes.