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Senior Regulatory Affairs Specialist

1 week ago
United States
Full-time
Senior
Compliance Manager
Legal
HIPAA
Apply Now
Radformation

Radformation

Radformation develops innovative software that enhances the efficiency and accuracy of radiation oncology treatment planning by providing a plugin for the Eclipse Treatment Planning System, which evaluates dosimetric constraints and treatment parameter...

Internet Software & Services
51-250
Founded 2016
$8M raised
View All Jobs 6

Description

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

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% as needed for audit support.
  • Software as a Medical Device (SaMD) experience preferred.
  • Product development experience preferred.
  • Strong project management skills preferred.
  • Experience with risk management processes and deliverables preferred.
  • Post-market surveillance, adverse event evaluation, and reporting experience preferred.
  • RAC certification preferred.

Benefits

  • Salary range of $90,000 to $150,000 USD base pay plus bonus eligibility.
  • Multiple medical plan options with substantial employer contributions and coverage starting on day one.
  • Short-term and long-term disability insurance plus life insurance.
  • 401(k) with immediate employer match vesting.
  • Annual reimbursement for professional memberships plus 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.

Interested in this position?

Apply directly on the company website

Apply Now

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