Find & Apply For Regulatory Affairs Specialist Jobs in Orem, Utah

PathRight Medical is seeking a Quality and Regulatory Specialist to support the company's quality management system and international regulatory activities. The role will include hands-on training in international registrations, renewals, distributor documentation, and ongoing market maintenance. As training progresses, the position will also support complaint handling, supplier management, document control, and other quality and regulatory activities. Prior regulatory experience is not required, but strong attention to detail, organization, and the ability to learn quickly are essential. Key Responsibilities Quality & Regulatory Support

• Support the company's Quality Management System and applicable regulatory requirements.
• Assist with complaint investigations, corrective and preventive actions (CAPA), supplier quality activities, document control, and internal audits.
• Maintain quality and regulatory records in an audit-ready state.
• Participate in continuous improvement activities and cross-functional quality initiatives. International Regulatory Support
• Support international product registrations, renewals, amendments, and ongoing registration maintenance.
• Prepare and organize documentation required for regulatory submissions in international markets.
• Maintain registration trackers, including status, expiration dates, and country-specific requirements.
• Respond to distributor requests for regulatory documentation, including Certificates of Free Sale and other market-specific documents.
• Coordinate with international distributors, Authorized Representatives, and internal teams to support regulatory activities.
• Assist with regulatory research and market entry requirements for new international markets. Training & Professional Development
• Receive hands-on training in international medical device registrations and global regulatory requirements.
• Develop practical experience supporting a medical device Quality Management System, including complaint handling, CAPA, supplier management, and internal audits.
• Gain exposure to medical device regulations, international market access, and regulatory documentation.
• Work alongside experienced quality and regulatory professionals while developing the knowledge and skills needed for increasing responsibility. Qualifications Required
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office, particularly Excel, and the ability to quickly learn new software.
• Ability to manage multiple projects and deadlines.
• Strong analytical and problem-solving skills with the ability to independently research unfamiliar topics.
• Ability to work both independently and collaboratively in a team environment. Preferred
• Experience in a regulated industry, such as medical devices, pharmaceuticals, or biotechnology.
• Familiarity with quality management systems or regulatory affairs.
• Experience with technical documentation or document control.
• Knowledge of

FDA, ISO

13485, or international medical device regulations.

• Proficiency in a second language. Why Join PathRight Medical?
• Gain hands-on experience in both quality systems and international medical device regulatory affairs.
• Receive mentorship from experienced quality and regulatory professionals.
• Contribute directly to products that improve patients' quality of life around the world.
• Work in a collaborative, growing company where your contributions have a meaningful impact.
• Develop skills and responsibilities that grow with your experience.

Pay:

$25.00 per hour

Benefits:

Flexible schedule Paid time off

Work Location:

In person