Senior Regulatory Affairs Specialist

About Radformation Radformation is transforming the way cancer clinics deliver care. Our innovative software automates and standardizes radiation oncology workflows, enabling clinicians to plan and deliver treatments faster, safer, and more consistently, so patients everywhere can receive the same high-quality care. Our software focuses on three key areas: • Time savings through automation • Error reduction through automated systems • Increased quality care through advanced algorithms and workflows We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every customer interaction brings us closer to ensuring treatment quality never depends on geography. Why This Role Matters 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. Responsibilities Include • 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 Required Experience • 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 Preferred Experience • 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 AI & Hiring Integrity At Radformation, we believe AI can be an incredible tool for innovation, but our hiring process is about getting to know you, your skills, experience, and unique approach to problem solving. We ask that all interviews and assessments be completed without tools that generate answers in real time. This helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may affect your candidacy. Benefits & Perks — What Makes Us RAD We care about our people as much as our mission. We offer competitive compensation, comprehensive benefits, and the opportunity to make a meaningful impact in the fight against cancer. Salary range: $90,000 - $150,000 USD base salary, plus bonus eligibility For US teammates (via TriNet): Health & Wellness • Multiple high-quality medical plan options with substantial employer contributions • Health coverage starting day one • Short-term and long-term disability and life insurance Financial & Professional Growth • 401(k) with immediate employer match vesting • Annual reimbursement for professional memberships • Conference attendance and continued learning opportunities Work-Life Balance & Perks • 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 Our Commitment to Diversity Cancer affects people from every walk of life, and we believe our team should reflect that diversity. Radformation is proud to be an equal opportunity workplace and an affirmative action employer. We welcome candidates from all backgrounds and are committed to fostering an inclusive environment for all employees. Agency & Candidate Safety Notice Radformation does not accept unsolicited resumes from agencies without a signed agreement in place. We do not partner with third-party recruiters unless explicitly stated. All legitimate communication from Radformation will come from an @radformation.com email address. If you receive outreach from another domain or via unofficial channels, please contact [email protected].