Senior Regulatory Affairs Specialist – Clinical Usability

Radformation

Senior Regulatory Affairs Specialist ensuring compliance for SaMD products at Radformation. Leading usability studies and regulatory submissions to meet global requirements.

Posted 4/17/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $90,000 - $150,000 per yearWebsite

About the role

Key responsibilities & impact

Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance.
Lead the construction and execution of both formative and summative usability activities for SaMD applications
Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability
Work with customer contact and product application specialists to oversee the execution of Usability studies
Map existing Clinical Deliverables to global requirements for clinical evidence and reporting
Drive execution of PMCF and PMS activities and reporting
Represent Radformation in Compliance Audits and Conformity Assessments, specifically regarding usability and Clinical documentation
Author or revise SOPs to improve regulatory compliance of the Quality System

Requirements

What you’ll need

8 years of regulatory affairs experience with a Bachelor's degree (B.A/B.S. required); >6 years of experience with a Master's or other advanced degree in a related field
Software as a medical device (SaMD) experience
Lead and/or author 510k or MDR submission experience
Experience in creating or contributing to usability studies, Analyzing Results and Generating Reports
Experience Creating and/or Contributing to CER/CEP/PMCF and PMS activities, specifically in relation to EU-MDR Medical Devices
Familiarity with global medical device regulations; 21 CFR 820 (QMSR), CMDR, EU MDD/MDR, ASIA PAC, LATAM, etc.
Demonstrated understanding of ISO 13485, MDSAP, ISO 14971, GSPR, GDPR, HIPPA and other international regulations/directives/standards
Experience writing content for regulatory submissions (CER/CEP/Tech Papers/Reports/RBA...)

Benefits

Comp & perks

Multiple high-quality medical plan options with substantial employer contributions
Health coverage starting day one
Short-term and long-term disability and life insurance
401(k) with immediate employer match vesting
Annual reimbursement for professional memberships
Conference attendance and continued learning opportunities
Self-managed PTO and 10 paid holidays
Monthly internet stipend
Company-issued laptop and one-time home office setup stipend
Fully remote work environment with virtual events and yearly retreats

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsusability studiesregulatory submission content510k submissionMDR submissionCERCEPPMCFPMS activitiesdata analysis

Soft Skills

leadershipcommunicationcollaborationorganizational skillsproblem-solving

Certifications

Bachelor's degreeMaster's degreeISO 13485MDSAPISO 14971