Medical Device Design Controls Specialist

Location: Remote, USA (Eastern/Central Time Zones)Employment Type: Full-TimeAbout RadformationRadformation 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 conversation with our customers brings us closer to ensuring no patient’s treatment quality depends on where they live. WhyThis Role MattersIn this role, you will serve as the primary liaison between the Product and Regulatory teams to ensure conformance and timely completion of all product deliverables, submissions, and releases.You will work closely with the Director of Product Management, the Director of Product Quality, and cross-functional partners across Product and Quality to support and maintain Design History Files (DHFs) for Radformation’s software products. Your work directly supports our mission to deliver safe, effective, and compliant solutions that improve the quality and efficiency of cancer treatment. Responsibilities Include:• Liaise between Product and Regulatory teams for all product DHF deliverables. • Drive timelines for product deliverables, ensuring timely release and/or submission.• Create and maintain project-specific technical file deliverable lists aligned with internal SOPs. • Confirm appropriate templates are used for each deliverable and coordinate updates with the team. • Partner with project leaders, RA, and Quality to ensure deliverable owners understand expectations, receive guidance, and escalate risks as needed. • Track deliverables using company eQMS and ALM systems. • Present product-related deliverables during inspections and internal/external audits. • Support Jira–ALM integration and assist with deliverable management.• Consult with Product and Regulatory teams on content and interpret regulatory intent and expectations. • Implement regulatory feedback into the Product DHF and update tools or practices as requirements evolve. • Support substantial equivalence evaluations and conformity assessments when needed. RequiredExperience:• 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience. • 3+ years in a regulatory project management or technical role. • Experience working in a regulated agile development environment.• Familiarity with global medical device regulations: QSR/QMSR, MDD/CMDR/MDR. • Experience with eQMS and ALM systems, including enacting QMS requirements including Matrix. • Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards. PreferredExperience:• Direct product development experience. • Project Management Institute (PMI) certification or similar credential. Who You Are• Clear communicator and believe the team succeeds or fails together.• Highly motivated with strong attention to detail. • Adaptable and thrive in a fast-paced, evolving environment. • You take ownership of your work and have strong prioritization skills. • Committed to improving the patient experience. • You have excellent organizational and interpersonal skills and can manage multiple projects simultaneously. Benefits & Perks — What Makes Us RADWe care about our people as much as we care about our mission. We offer competitive compensation, benefits, and the opportunity to make an impact in the fight against cancer.The salary range for this role is $140,000 – $170,000 USD base. In addition we offer:• Multiple high-quality medical plan options with substantial employer contributions toward premiums, often covering the full cost depending on the plan selected. • Health coverage starting on day one. • Short-term and long-term disability and supplementary life insurance. • 401(k) with employer match vested immediately. • Annual reimbursement for professional memberships. • Conference attendance and continued learning opportunities.• Self-managed PTO and 10 paid holidays. • Monthly internet stipend 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 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 NoticeRadformation 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]. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses.These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Apply tot his job