New · posted Oct 29
Bruker · Medical Devices
Regulatory Affairs Specialist
- Logan, UT
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
- 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 Qualificationsnice to have
- 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.
What you'll do
- 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.
Where you'll work
Logan, UTOn-siteOpen in Maps (opens in a new tab)
More jobs in Logan, UTJob intelligence
The context around this role
Live data · October 29, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $84,000 | $92,000 | $96,375 |
Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 312 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Bruker's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- GMP and compliance5
- Quality systems and risk4
- Documentation and SOPs3
- Collaboration and leadership3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
Company hiring pulse
Bruker on Regulatory Jobs
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- Open roles
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Regulatory Affairs Specialist at Bruker
Applications close October 28.