Regulatory Affairs Specialist

Job overview

Compensation is not specified. The Regulatory Affairs Specialist role is onsite in Logan, UT. The specialist supports regulatory compliance for diagnostics products across their lifecycle, from development and registration through post-market surveillance. The role helps ensure products meet applicable global requirements and supports regulatory submissions, product development, and ongoing compliance. By coordinating with regulatory agencies and internal teams, the specialist contributes to the company’s regulatory strategy and product lifecycle activities.

What you'll do

• Implement regulatory affairs procedures
• prepare and compile regulatory documentation, including 510(k), PMA, and CE Technical Files, and manage submissions with guidance from the Regulatory Affairs Manager
• interpret and apply FDA, EU MDR, ISO 13485, and other international regulations
• collaborate with R&D, Quality, Clinical, and Marketing
• review product labeling, instructions for use, and promotional materials
• monitor regulatory changes
• support audits and inspections
• maintain regulatory files and databases
• participate in post-market surveillance and adverse event reporting
• provide input to risk assessments and design controls.

What we're looking for

Skills & competencies

regulatory affairs specialist

diagnostics products

fda regulations

eu mdr

iso 13485

regulatory submissions

product registration

post-market surveillance

medical devices

logan ut

elitechgroup

Work arrangement

• Weekend coverage required

Why this role

The role covers global regulatory requirements for diagnostics products and includes submissions, audits, and post-market surveillance; a bachelor’s degree and 2–5 years of regulatory affairs experience are listed qualifications.

About the employer

ELITechGroup Inc. is hiring for this role. Industry: All Other Miscellaneous Chemical Product and Preparation Manufacturing. Sector: 32.