Global Regulatory Strategist – Medical Diagnostics

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

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