Global Regulatory Affairs Specialist - Diagnostics

UNAVAILABLE; Logan (UT); On-site; USD 85,000 - 110,000; Full time

Job summary

ELITechGroup Inc. seeks a Regulatory Affairs Specialist to ensure global regulatory compliance for diagnostic products throughout development, registration, and post-market surveillance. You will collaborate with R&D, Quality, Clinical, and Marketing to implement procedures and maintain regulatory files.

The ideal candidate has strong knowledge of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485, with experience in multiple markets. Familiarity with eSTAR and EUDAMED is a plus.

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• 2–5 years of regulatory affairs experience, preferably in the medical device industry.
• Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
• Experience with regulatory submissions and product registrations in multiple global markets.
• Excellent written and verbal communication skills.
• Strong organizational and project management abilities.

Responsibilities

• Implement company regulatory affairs procedures.
• Prepare, compile, and submit regulatory documentation to global regulatory agencies and manage submissions with guidance from Regulatory Affairs Manager.
• Interpret and apply FDA, EU MDR, ISO 13485 regulations to ensure product compliance.
• Collaborate with cross-functional teams to support product development and regulatory strategy.
• Review and approve labeling, IFUs, and promotional materials for regulatory compliance.
• Monitor and communicate changes in regulatory requirements to internal stakeholders.
• Support audits, including FDA inspections and Notified Body assessments.
• Maintain regulatory files and databases with accurate documentation.
• Participate in post-market surveillance activities including adverse event reporting.
• Provide regulatory input during risk assessments and design control processes.

Skills

Communication

Organizational skills

Project management

Regulatory affairs knowledge

Education

Bachelor's degree in Life Sciences/Regulatory Affairs

Tools

eSTAR

EUDAMED

Job description

ELITechGroup Inc. seeks a Regulatory Affairs Specialist to ensure global regulatory compliance for diagnostic products throughout development, registration, and post-market surveillance. You will collaborate with R&D, Quality, Clinical, and Marketing to implement procedures and maintain regulatory files.

The ideal candidate has strong knowledge of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485, with experience in multiple markets. Familiarity with eSTAR and EUDAMED is a plus.