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.