Regulatory Affairs Specialist

Prentke Romich Company; Wooster (OH); On-site; USD 55,000 - 90,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory research

Regulatory compliance

Communication skills

Analytical thinking

Audit participation

Stakeholder collaboration

Multitasking

Organizational skills

Problem solving

5+ years regulatory experience

Education

Bachelor’s Degree in Life Sciences/Engineering/Business

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Help Bring Innovative Communication Solutions to Market – Join PRC-Saltillo as a Regulatory Affairs Specialist!

At PRC-Saltillo, our mission is to empower individuals through innovative communication solutions. As a Regulatory Affairs Specialist, you’ll play a key role in ensuring our medical devices and software products meet regulatory requirements across the United States, Canada, Europe, and other global markets. You’ll collaborate with cross-functional teams, provide regulatory guidance, manage product registrations, and help bring life-changing technology to the people who depend on it.

If you're passionate about regulatory compliance, enjoy solving complex challenges, and want to make a meaningful impact in a mission-driven organization, we’d love to hear from you!

Why You’ll Love Working Here

• Meaningful Impact: Help ensure innovative communication technologies reach the individuals who rely on them.
• Global Reach: Support regulatory activities across multiple international markets and regulatory bodies.
• Collaborative Environment: Work closely with engineering, quality, product development, and business teams.
• Professional Growth: Expand your expertise in medical device regulations, software as a medical device (SaMD), and global compliance requirements.

Duties and Responsibilities

• Manage regulatory submissions, registrations, renewals, and related documentation to support compliance in domestic and international markets.
• Provide regulatory guidance for product development, manufacturing, labeling, marketing, distribution, and market expansion activities.
• Create, maintain, and support technical documentation, product registrations, Declarations of Conformity, and regulatory files.
• Review product changes, labeling, marketing materials, and documentation to ensure compliance with applicable regulations.
• Monitor regulatory changes, assess business impact, and recommend process improvements to maintain compliance.
• Represent Regulatory Affairs on project teams and provide regulatory expertise across the organization.
• Support risk assessments, product recalls, medical device reporting activities, and regulatory audits as needed.

Education and Experience

• Bachelor’s Degree in Life Sciences, Engineering, Business, or a related technical field is required.
• A minimum of five (5) years of regulatory affairs experience in a regulated environment such as medical devices, pharmaceuticals, or biotechnology is required.
• Knowledge of Microsoft Word, Excel, and PowerPoint is required.

Required Skills and Abilities

• Ability to conduct detailed regulatory research, analysis, and compliance assessments.
• Strong understanding of regulatory requirements and quality system standards.
• Excellent written and verbal communication skills with the ability to explain complex regulatory concepts to diverse audiences.
• Strong analytical, critical thinking, and problem-solving abilities.
• Ability to lead or participate in regulatory and compliance audits.
• Demonstrated ability to collaborate effectively with internal and external stakeholders.
• Self-motivated, adaptable, and able to manage multiple priorities in a changing environment.
• Strong organizational skills and attention to detail.