Radformation - Senior Regulatory Affairs Specialist
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Requirements
• >8 years of regulatory affairs experience with a Bachelor's degree (B.A/B.S. required); >6 years of experience with a Master's or other advanced degree in a related field • Software as a medical device (SaMD) experience • Lead and/or author 510k or MDR submission experience • Experience in creating or contributing to usability studies, Analyzing Results and Generating Repots • Experience Creating and/or Contributing to CER/CEP/PMCF and PMS activities, specifically in relation to EU-MDR Medical Devices • Familiarity with global medical device regulations; 21 CFR 820 (QMSR), CMDR, EU MDD/MDR, ASIA PAC, LATAM, etc. • Demonstrated understanding of ISO 13485, MDSAP, ISO 14971, GSPR, GDPR, HIPPA and other international regulations/directives/standards • Exceptional communication (written and oral) skills • Experience writing content for regulatory submissions (CER/CEP/Tech Papers/Reports/RBA...) • Willingness to travel when required; up to 5% (audit support) • Cross-skilled in QMS • Completing Regulatory Impact Assessments • Risk Management Processes and Deliverables • RAC Certification is a plus • AI & Hiring Integrity
Responsibilities
• Develop an efficient and effective Usability program consistent with international regulatory requirements and FDA guidance. • Lead the construction and execution of both formative and summative usability activities for SaMD applications • Generate Regulatory Submission content for Usability Engineering, including Plans, Reports, Use Error Analysis and Traceability • Work with customer contact and product application specialists to oversee the execution of Usability studies • Map existing Clinical Deliverables to global requirements for clinical evidence and reporting • Work with existing Clinical Affairs Medical Physicist to Champion efficiency improvements in our CEP/CER/PMCF and PMS processes and deliverables • Drive execution of PMCF and PMS activities and reporting • Represent Radformation in Compliance Audits and Conformity Assessments, specifically regarding usability and Clinical documentation • Assess New Feature and Product planning documents to determine potential Clinical and Usability needs • Collaborate with cross-functional partners in driving and implementing new processes, primarily but not limited to Usability Engineering, Clinical Affairs and Post Market Surveillance • Interact with regulatory authorities as needed during the development and review process to ensure submission approval • Author or revise SOPs to improve regulatory compliance of the Quality System • Monitor the impact on Clinical and Usability of changing global regulations on submission strategies & registrations • Occasional Travel - Domestic and International • Perform other quality and regulatory duties as assigned
Benefits
• As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring Radformation's Software as a Medical Device products meet global regulatory requirements related to usability engineering and clinical reporting. You will bring a deep expertise in SaMD regulatory expectations, including FDA guidance on applying human factors and usability engineering to medical devices, as well as EU MDR conformity assessment requirements for clinical evidence. Working closing with the VP of Regulatory Affairs, VP of Product and Regulatory Principal, you will help drive completion of critical usability and clinical deliverables, support regulatory compliance across the product life cycle, and strengthen the processes needed to scale Radformation's regulatory function as the company grows. • 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]. • 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.
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