Regulatory Affairs Specialist

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

Job summary

Bruker Daltonics is seeking a Regulatory Affairs Specialist to ensure compliance of diagnostics products across development, registration and post-market stages. You will prepare submissions (510(k), PMA, CE Technical Files) and interpret FDA, EU MDR, ISO 13485 requirements, collaborating with R&D, QA, Clinical and Marketing to drive regulatory strategy and timely product approvals.

You will maintain regulatory documentation, support audits, monitor regulatory changes, and contribute to

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 2–5 years of regulatory affairs experience in medical devices.
• Strong understanding of FDA 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 for ELITechGroup Inc.
• Prepare, compile, and submit regulatory documentation (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 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.

Skills

Regulatory affairs

FDA regulations

Regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field (Life Sciences, Biomedical Engineering, Regulatory Affairs)

Tools

eSTAR

EUDAMED

MDSAP

ISO 14971

Job description

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.