Senior Regulatory Affairs Specialist

Radformation

14d • $90,000 - $150,000 • Remote

About The Position

As a Regulatory Affairs Senior Specialist, you will play a critical role in ensuring Radformation’s Software as a Medical Device products meet global regulatory requirements throughout the product life cycle. You will work closely with the VP of Regulatory Affairs, Principal Regulatory leadership, and cross-functional teams to support U.S. and international registrations, guide regulatory strategy for product changes, and help scale regulatory processes as the company grows. Your work directly supports patient safety, regulatory compliance, and the timely delivery of innovative cancer care technology.

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

Nice To Haves

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

Responsibilities

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level