Regulatory Affairs Specialist

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

Overview

This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle—from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products of ELITechGroup Inc. with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.

Responsibilities

• Implement company regulatory affairs procedures for ELITechGroup Inc.
• Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
• Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
• Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
• Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
• Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
• Support internal and external audits, including FDA inspections and Notified Body assessments.
• Maintain regulatory files and databases, ensuring accurate and up-to-date documentation.
• Participate in post-market surveillance activities, including adverse event reporting and field actions.
• Provide regulatory input during risk assessments and design control processes.

Qualifications

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• 2–5 years of experience in regulatory affairs, 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.

Preferred Qualifications

• RAC certification (Regulatory Affairs Certification).
• Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
• Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.