About the role
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.
Compensation: $60,000 - $75,000