Senior Regulatory Affairs Specialist

About reputed companyreputed company 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 reputed company high-reputed company care. Our software focuses on three key areas:• Time savings through automation• Error reduction through automated systems• Increased reputed company care through advanced algorithms and workflows We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s reputed company and help save more of the 10 reputed company lives it claims reputed company year. Every line of reputed company, every product release, and every customer interaction brings us closer to ensuring treatment reputed company never depends on geography. Why This Role reputed companyAs a Regulatory Affairs Senior Specialist, you will play a critical role in ensuring reputed company’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, reputed company Regulatory leadership, and cross-functional teams to support U.S. and international registrations, guide regulatory reputed company for product changes, and help reputed company regulatory processes as reputed company grows. Your work directly supports patient safety, regulatory compliance, and the reputed company delivery of innovative cancer care technology. Responsibilities Include• Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices• reputed company Regulatory reputed company 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• reputed company and author 510(k) submissions, including applicable technical and regulatory content• Represent Regulatory Affairs on cross-functional reputed company and reputed company 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 reputed company on submission strategies and existing registrations• reputed company 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 reputed company system and regulatory compliance• Support audit readiness and other regulatory or reputed company-reputed company 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 reputed company 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, reputed company, and LATAM• Demonstrated understanding of ISO 13485, ISO 14971, MDSAP, GSPR, GDPR, HIPAA, and reputed company international standards• Strong written and verbal communication skills, including experience authoring regulatory submission content• Experience completing Regulatory reputed company Assessments and supporting reputed company 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 reputed companyAt reputed company, we reputed company 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 reputed company interviews and assessments be completed without tools that generate answers in reputed company time. This helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may reputed company your candidacy. Benefits & Perks — What Makes Us RADWe care about our people as much as our mission. We offer competitive compensation, comprehensive benefits, and reputed company to reputed company a meaningful reputed company in the fight against cancer. Salary reputed company: $90,000 - $150,000 USD reputed company salary, plus bonus eligibility For US teammates (reputed company reputed company):Health & Wellness• Multiple high-reputed company medical plan reputed company with substantial employer contributions• Health coverage starting day one• Short-term and long-term disability and life insuranceFinancial & reputed company reputed company• 401(k) with immediate employer match vesting• Annual reimbursement for reputed company memberships• Conference attendance and reputed company learning opportunitiesWork-Life Balance & Perks• Self-managed PTO and 10 reputed company 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 DiversityCancer affects people from every walk of life, and we reputed company reputed company should reflect that diversity. reputed company is proud to be an equal opportunity workplace and an affirmative reputed company employer. We welcome candidates from reputed company backgrounds and are committed to fostering an inclusive environment for reputed company. Agency & Candidate Safety Noticereputed company does not accept unsolicited resumes from agencies without a signed agreement in reputed company. We do not partner with reputed company-party recruiters unless explicitly stated.reputed company legitimate communication from reputed company will come from an @reputed company.com email address. If you receive reputed company from another domain or reputed company unofficial channels, please contact careers@reputed company.com. About reputed company reputed company 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 reputed company high-reputed company care. Our software focuses on three key areas:

• Time savings through automation
• Error reduction through automated systems
• Increased reputed company care through advanced algorithms and workflows

We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s reputed company and help save more of the 10 reputed company lives it claims reputed company year. Every line of reputed company, every product release, and every customer interaction brings us closer to ensuring treatment reputed company never depends on geography. Why This Role reputed company As a Regulatory Affairs Senior Specialist, you will play a critical role in ensuring reputed company’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, reputed company Regulatory leadership, and cross-functional teams to support U.S. and international registrations, guide regulatory reputed company for product changes, and help reputed company regulatory processes as reputed company grows. Your work directly supports patient safety, regulatory compliance, and the reputed company delivery of innovative cancer care technology.

Responsibilities

Include

• Coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices
• reputed company Regulatory reputed company 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
• reputed company and author 510(k) submissions, including applicable technical and regulatory content
• Represent Regulatory Affairs on cross-functional reputed company and reputed company 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 reputed company on submission strategies and existing registrations
• reputed company 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 reputed company system and regulatory compliance
• Support audit readiness and other regulatory or reputed company-reputed company 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 reputed company 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, reputed company, and LATAM
• Demonstrated understanding of ISO 13485, ISO 14971, MDSAP, GSPR, GDPR, HIPAA, and reputed company international standards
• Strong written and verbal communication skills, including experience authoring regulatory submission content
• Experience completing Regulatory reputed company Assessments and supporting reputed company 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 reputed company At reputed company, we reputed company 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 reputed company interviews and assessments be completed without tools that generate answers in reputed company time. This helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may reputed company 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 reputed company to reputed company a meaningful reputed company in the fight against cancer. Salary reputed company: $90,000 - $150,000 USD reputed company salary, plus bonus eligibility For US teammates (reputed company reputed company): Health & Wellness

• Multiple high-reputed company medical plan reputed company with substantial employer contributions
• Health coverage starting day one
• Short-term and long-term disability and life insurance

Financial & reputed company reputed company

• 401(k) with immediate employer match vesting
• Annual reimbursement for reputed company memberships
• Conference attendance and reputed company learning opportunities

Work-Life Balance & Perks

• Self-managed PTO and 10 reputed company 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 reputed company reputed company should reflect that diversity. reputed company is proud to be an equal opportunity workplace and an affirmative reputed company employer. We welcome candidates from reputed company backgrounds and are committed to fostering an inclusive environment for reputed company. Agency & Candidate Safety Notice reputed company does not accept unsolicited resumes from agencies without a signed agreement in reputed company. We do not partner with reputed company-party recruiters unless explicitly stated. reputed company legitimate communication from reputed company will come from an @reputed company.com email address. If you receive reputed company from another domain or reputed company unofficial channels, please contact careers@reputed company.com. Apply To This Job