Regulatory Affairs Specialist

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!

Go to our website to apply https://prentkeromich.bamboohr.com/careers

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.