Regulatory Affairs Specialist

ELITechGroup; Logan (UT); On-site; USD 65,000 - 95,000; Full time

Job summary

ELITechGroup is seeking a Regulatory Affairs Specialist to ensure products comply with global regulatory requirements throughout development, registration, and post-market activities. You will prepare submissions (FDA/CE), interpret applicable regulations, and support cross-functional teams across R&D, Quality, and Marketing.

The role emphasizes collaboration, documentation, and ongoing regulatory monitoring to align with business objectives while maintaining compliance across multiple markets.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–5 years of regulatory affairs experience, preferably in medical devices.
• Familiarity with FDA (21 CFR Part 820), EU MDR, ISO 13485; RAC preferred.

Responsibilities

• Prepare regulatory submissions (e.g., 510(k), PMA, CE Technical Files) for global markets.
• Interpret FDA, EU MDR, and ISO 13485 requirements to ensure product compliance.
• Collaborate with R&D, Quality, Clinical, and Marketing to support regulatory strategy.
• Review labeling, IFUs and promotional materials for regulatory compliance.
• Monitor regulatory changes and communicate updates to stakeholders.
• Support audits including FDA inspections and Notified Body assessments.
• Maintain regulatory files and databases with accurate documentation.
• Participate in post-market surveillance and adverse event reporting.

Skills

Regulatory knowledge

Regulatory submissions

Regulatory compliance

Communication

Education

Bachelor's degree in Life Sciences

RAC certification

Tools

eSTAR

EUDAMED

MDSAP

Job description

Summary

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 with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.

Essential Duties and Responsibilities

• Implement company regulatory affairs procedures.


• 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

• 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.