NuWest Group · 13 hours ago
Regulatory Engineer
Bellevue, WA
Full-time
Onsite
Mid, Senior Level
$110K/yr - $150K/yr
4+ years expNuWest Group is seeking a Medical Device Regulatory Engineer responsible for ensuring compliance of medical devices with regulatory requirements in various markets. The role involves supporting product development, registration, and post-market compliance while collaborating with cross-functional teams.
Enterprise SoftwareInformation TechnologyCRM
Responsibilities
Develop and execute regulatory strategies for new and existing medical devices
Prepare and submit regulatory filings (e.g., FDA 510(k), PMA, De Novo, Technical Files, Design Dossiers)
Support global registrations (e.g., EU MDR, UKCA, Health Canada, TGA, etc.)
Author and review regulatory documentation including: Intended Use statements, Labeling and IFUs, Risk management files, Clinical evaluation reports
Coordinate responses to regulatory authority questions and deficiency letters
Ensure compliance with applicable regulations and standards, including: FDA 21 CFR Part 820 / QMSR, EU MDR (2017/745), ISO 13485, ISO 14971, IEC 60601 (if applicable)
Support internal and external audits
Maintain regulatory files and product technical documentation
Monitor regulatory changes and assess impact on products
Participate in design reviews and change control processes
Ensure regulatory requirements are integrated into product development
Review engineering documentation for regulatory compliance
Support verification, validation, and clinical activities as needed
Support post-market surveillance activities
Assist with complaint investigations and regulatory reporting (MDR, vigilance)
Maintain product registrations and renewals
Qualification
Required
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Life Sciences, or related field
4–8+ years of regulatory affairs experience in the medical device industry
Strong understanding of global medical device regulations
Familiarity with quality systems and design controls
Excellent technical writing and documentation skills
Strong analytical and problem-solving abilities
Ability to manage multiple projects in a fast-paced environment
Effective cross-functional communication skills
Preferred
Experience preparing and submitting FDA 510(k) submissions strongly preferred
Experience with EU MDR technical documentation preferred
RAC (Regulatory Affairs Certification)
Experience with Class II or Class III medical devices
Experience working in a start-up or fast-growing environment
Knowledge of software as a medical device (SaMD) regulations (if applicable)
Company
NuWest Group
At NuWest Group, we pride ourselves on providing the highest level of customer service to our clients and candidates.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Traci Danek
President
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