Global Regulatory Affairs Specialist – Medical Devices

Bruker; Logan (UT); On-site; USD 75,000 - 110,000; Full time

Job summary

ELITechGroup Inc. is seeking a Regulatory Affairs Specialist to ensure global regulatory compliance for diagnostics products across their lifecycle, including development, registration, and post-market surveillance.

You will prepare regulatory submissions and work with FDA, EU MDR, and ISO standards while coordinating with R&D, Quality, Clinical, and Marketing teams. The role involves reviewing labeling, IFUs, and promotional materials, tracking regulatory changes, and supporting audits and

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.

Responsibilities

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

Skills

Regulatory affairs

Regulatory submissions

Communication

Organization & PM

Education

Bachelor's degree in Life Sciences/Regulatory Affairs

Tools

eSTAR

EUDAMED

Job description

ELITechGroup Inc. is seeking a Regulatory Affairs Specialist to ensure global regulatory compliance for diagnostics products across their lifecycle, including development, registration, and post-market surveillance.

You will prepare regulatory submissions and work with FDA, EU MDR, and ISO standards while coordinating with R&D, Quality, Clinical, and Marketing teams. The role involves reviewing labeling, IFUs, and promotional materials, tracking regulatory changes, and supporting audits and