Rakuten Medical

Lead and manage the Quality Management System for medical combination drug-device products ensuring regulatory compliance and operational excellence. | 8-10 years managing quality systems in regulated industries with certifications like ISO 13485 Lead Auditor and experience in FDA and ISO audits. | Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com. Position Summary We are seeking a highly skilled Quality Systems Engineering Manager to lead the Quality Management System (QMS) for our medical combination drug-device products. This is a critical leadership role requiring expertise in managing compliance for the development, manufacturing, and delivery of products that integrate drug and device technologies. As the QMS leader, you will shape quality strategies, drive regulatory compliance, and foster a culture of operational excellence. Key Duties and Responsibilities Quality Management System (QMS) Leadership: Oversee the implementation, maintenance, and improvement of the QMS to ensure compliance with ISO 13485:2016, FDA 21 CFR Parts 820, 210/211, GMP, and other global regulations. Lead Management Reviews, ensuring top-level engagement in quality objectives, process optimization, risk management, and regulatory compliance. ISO 13485: 2016 Lead Auditor Certification: Apply expertise as a Certified Lead Auditor to conduct internal audits and prepare for external inspections by notifying bodies, regulatory authorities, and third-party auditors. Ensure alignment with key elements of ISO 13485, including risk-based approaches, process validation, product traceability (Clause 7.5), and post-market surveillance (Clause 8.2.3). Document Control & Arena QMS: Lead/manage document control processes utilizing Arena for product lifecycle management. Oversee correct documentation of all quality activities required for audit readiness, including design controls, supplier files, production records, and complaint handling processes. Supplier Quality Management: Oversee supplier qualification, monitoring, and auditing processes against medical device and pharmaceutical compliance requirements. Manage supplier risk assessments, approve SCARs (Supplier Corrective Action Requests), and monitor CAPA implementation by external vendors. Ensure design and process risk management using ISO 14971 for hazard analysis and product safety assessments. Drive interdepartmental collaboration for effective QMS training and decision-making at all stages of product life. CAPA, Non-Conformances, and SCARs: Own and manage the end-to-end CAPA and non-conformance systems, including investigation, root cause analysis, and oversight of preventive actions. Ensure data-driven decisions using trends from SCARs, audits, and deviations to improve processes. Training and Development: Develop robust QMS training programs to foster compliance and awareness across all functional teams, utilizing your knowledge of regulatory standards like ISO 13485, FDA requirements, and GMP/GDP. Audit Preparedness and Leadership: Lead preparation for external audits and regulatory inspections, ensuring readiness for ISO 13485 compliance, FDA audits, and post-market audits. Define and implement continuous improvement programs to address audit findings proactively. Key Qualifications: Education: Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s degree or advanced certification preferred. Certifications: ISO 13485:2016 Lead Auditor Certification (required). Preferred certifications: CQE (Certified Quality Engineer), RAC (Regulatory Affairs Certification). Experience: Minimum 8-10 years of experience managing quality systems in regulated industries, specifically for pharmaceutical, medical devices, or combination products. Strong working knowledge of ISO standards, FDA regulations, and international regulatory frameworks, including EU MDR (Medical Device Regulation). Proven track record of managing complaint handling, CAPA systems, SCARs, and supplier qualification programs. Preferred Knowledge & Skills: Technical Tools: Proficiency in QMS software (e.g., Arena, MasterControl, or others). Audit Experience: Demonstrated success leading FDA, ISO, and notified body audits with minimal findings. • Analytical mindset with strong problem-solving skills and a collaborative, team-first approach. • Travel: 10-15% We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills. The expected salary range for this position based in California is $140,000 to $160,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

Design and deliver training programs to healthcare professionals and internal teams to support clinical development and commercialization of a cancer therapy platform. | Requires an M.D. with surgical experience and extensive medical affairs or R&D experience in healthcare. | Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com. Position Summary This position plays a critical role in strengthening and accelerating the global medical and scientific impact of Rakuten Medical's Alluminox platform. Key responsibilities include designing and delivering training programs to external Health Care Professionals and internal teams in clinical development, operation and medical affairs/science functions. This role ensures that Alluminox technology is delivered to patient at the highest standard while gathering frontline feedback from medical society to enhance Rakuten Medical's research, development and commercialization efforts. Key Duties and Responsibilities • Design, organize, lead and execute training sessions for care professionals on product knowledge effectively • Ensure patients globally in both clinical trial and commercial settings are treated at the highest standards and if necessary to provide onsite support • Plan, organize, and execute Investigator Meetings, Advisory Board Meetings and other equivalent events and present on behalf of the company as needed • Support research, development and commercialization efforts through collecting and synthesizing observation in the medical field and clinicians' feedback • Develop robust partnership relationship with HCPs within current and future therapeutic area • Educating employees the insights and information gained from academic papers and conference • Identify challenges for the mid to long-term global R&D and medical communication and propose/execute solutions from medical perspective. Desired Education, Skills and Experience • M.D. degree and surgeon experience required • Specialty in otorhinolaryngology, gynecology or hepatology is a plus • 10-year + Medical affair and / or R&D related experiences in healthcare industry required • Demonstrated hands-on characteristics and proactiveness • Focused on actions, problem-solving and result oriented • Ability to establish strong partnership rapport with key internal and external stakeholders • Capability to effectively collaborate with cross-functional team and communicate with leadership team • Solid knowledge of the healthcare landscape such as hospital systems, various points of care, and the roles of relevant HCPs in the target Tas and the drug development process • Exceptional self-management ability and able to self-motivate • Strong understanding of compliance, and the legal and regulatory landscape as they relate to HCP interactions • Fluent in Medical English listening, speaking, writing and reading is a must, other second language is a plus • May require travel up to 50% We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills. The expected salary range for this position based in California is $180,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

Lead and manage quality systems, audits, and compliance in a regulated industry. | 8-10 years managing quality systems with ISO and FDA knowledge and QMS software proficiency. | Job Description: • Oversee the implementation, maintenance, and improvement of the QMS • Lead Management Reviews and ensure top-level quality engagement • Conduct internal audits and prepare for external inspections • Manage document control processes utilizing Arena for product lifecycle management • Oversee supplier qualification and auditing processes • Own and manage the CAPA and non-conformance systems Requirements: • Bachelor’s degree in Engineering, Life Sciences, or related field • ISO 13485:2016 Lead Auditor Certification (required) • Minimum 8-10 years of experience managing quality systems in regulated industries • Strong working knowledge of ISO standards and FDA regulations • Proficiency in QMS software (e.g., Arena, MasterControl) Benefits: • Flexible time off • Stock options • 401k • Medical plans • Dental plans • Vision plans