Global Regulatory Strategist – Medical Devices

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

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.