Radformation

Senior Regulatory Affairs Specialist

Radformation

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $90,000 - $150,000 per year

Job Level

Senior

About the role

  • Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices
  • Perform Regulatory Impact Assessments to determine registration implications for proposed product and design changes
  • Prepare and submit international regulatory filings in alignment with established timelines and business objectives
  • Lead and author 510(k) submissions, including applicable technical and regulatory content
  • Represent Regulatory Affairs on cross-functional projects and provide regulatory guidance throughout development and change management
  • Collaborate with internal teams to implement and improve regulatory processes, including registration tracking, reporting, and status management
  • Monitor global regulatory changes and assess their impact on submission strategies and existing registrations
  • Interact with regulatory authorities as needed during submission and review processes
  • Coordinate with international partners on product changes, regulatory notifications, and license maintenance
  • Author or revise SOPs to support ongoing quality system and regulatory compliance
  • Support audit readiness and other regulatory or quality-related initiatives as assigned

Requirements

  • 8+ years of regulatory affairs experience with a Bachelor’s degree, or 6+ years with a Master’s or advanced degree in a related field
  • Proven experience leading and authoring 510(k) and/or EU MDR submissions
  • Strong familiarity with global medical device regulations, including 21 CFR 820 (QMSR), EU MDR/MDD, CMDR, APAC, and LATAM
  • Demonstrated understanding of ISO 13485, ISO 14971, MDSAP, GSPR, GDPR, HIPAA, and related international standards
  • Strong written and verbal communication skills, including experience authoring regulatory submission content
  • Experience completing Regulatory Impact Assessments and supporting Quality Management Systems
  • Willingness to travel up to 5 percent as needed for audit support
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory impact assessments510(k) submissionsEU MDR submissionsregistration trackingreportingSOP authoringquality management systemsaudit readinessregulatory filingsregulatory guidance
Soft Skills
communication skillscollaborationleadershiporganizational skillsproblem-solving