Senior Regulatory Affairs Program Lead, MedTech Surgery Resume

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Senior Regulatory Affairs Program Lead, MedTech Surgery Resume Li Fowler Senior Regulatory Affairs Program Lead, MedTech Surgery (858) 555-6724 li.fowler@example.com linkedin.com/example/lifowler San Diego, CA 92121 STRENGTHS FDA Submission Leadership Owned Q submissions, IDEs, De Novo requests, and 510(k)s, giving review teams complete evidence and clear decisions. Cross Functional Influence When engineering evidence shifted, brought clinical, quality, and product partners together around a practical filing path. Regulatory Judgment Turned ambiguous software and hardware changes into documented impact assessments, helping teams choose sound next steps. Technical Communication FDA meeting briefs and rehearsal sessions gave senior partners confidence in questions, evidence, and response ownership. Submission Readiness Built traceable files across testing, risk, labeling, and software records, making audit requests easier to answer. SKILLS Regulatory strategy FDA submissions 510(k) IDE De Novo Q submissions Risk management Cybersecurity Medical devices Robotic surgery Software systems Health authority meetings Regulatory writing Life cycle management Cross functional leadership LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 10.1 Years Senior Regulatory Affairs Program Manager, Robotic Surgery Systems at Vela Robotic Surgery Systems (3.8 Years) Regulatory Affairs Manager, Connected Medical Platforms at Northstar Connected Medical (2.4 Years) Senior Regulatory Affairs Specialist, Surgical Devices at Meridian Surgical Devices (2 Years) Regulatory Affairs Specialist, Electromechanical Devices at Pacific Biomedical Instruments (1.9 Years) SUMMARY Senior regulatory affairs leader with 10 years of medical device experience spanning software enabled electromechanical systems, robotic surgery, connected medical platforms, and United States market access. Leads regulatory strategy across new product development , submissions, approvals, and life cycle management . Authors FDA Q submissions , IDEs, De Novo requests , and 510(k) submissions, then prepares teams for health authority meetings and review responses. Partners closely with engineering, clinical, quality, cybersecurity, and product teams on specifications, device testing, risk management, software documentation, labeling, and technical files. Applies FDA requirements, IEC 60601 series, ISO 10993 1, software guidance, and cybersecurity expectations to practical program decisions. Brings calm judgment to complex changes, audit support, regulatory intelligence, and cross functional delivery, helping medical device teams keep evidence complete, decisions traceable, and submissions ready. EXPERIENCE Senior Regulatory Affairs Program Manager, Robotic Surgery Systems Vela Robotic Surgery Systems January 2023 - Present San Diego, CA Leads regulatory strategy and execution for software enabled robotic surgical platforms, connecting United States submissions, global documentation, product development, sustaining changes, and health authority engagement across engineering, clinical, quality, cybersecurity, and product teams. Aligned robotic platform strategy with engineering, clinical, quality, cybersecurity, and development milestones. Authored Q submissions, IDE materials, De Novo content, and 510(k) evidence packages for FDA review. Identified submission gaps across specifications, testing, risk files, labeling , software, and cybersecurity evidence. Converted FDA guidance updates into impact assessments and documented decisions supporting business priorities. Directed change assessments , Letters to File , registrations, renewals, and sustaining submission recommendations. Prepared FDA meeting briefs, question strategy, rehearsals, action tracking, global files, and audit evidence. Regulatory Affairs Manager, Connected Medical Platforms Northstar Connected Medical July 2020 - December 2022 Irvine, CA Managed United States regulatory programs for connected electromechanical devices with embedded software, guiding products from design development through clearance, post market change evaluation, global documentation, and quality system audit support. Managed connected device programs from design development through FDA clearance and post market evaluation. Coordinated 510(k) submissions and pre submission packages across testing, software files, risk records, and labeling. Applied IEC 60601 series and ISO 10993 1 requirements to electrical safety and biological evaluation evidence. Assessed software and cybersecurity changes, documenting FDA impact and appropriate filing or internal justification. Prioritized concurrent product workstreams, resolved evidence needs, and maintained clear regulatory decision records. Supported FDA interactions, global submissions, and quality audits with traceable technical responses. Senior Regulatory Affairs Specialist, Surgical Devices Meridian Surgical Devices June 2018 - June 2020 Carlsbad, CA Executed regulatory activities for minimally invasive surgical devices and accessories, supporting United States submissions, product changes, technical documentation, labeling, regulatory intelligence, and audit readiness with clinical, quality, and engineering partners. Prepared 510(k) dossier sections linking testing, risk evidence, device descriptions, claims, and labeling. Reviewed engineering changes and documented Letters to File or submission recommendations using FDA requirements. Closed documentation gaps with clinical, quality, and engineering partners before submission milestones. Monitored FDA guidance and standards updates, then summarized project impacts for active development teams. Maintained design to claim traceability across technical documentation , risk records, and approved labeling. Retrieved submission records, registrations , change assessments , and correspondence during quality system audits. Regulatory Affairs Specialist, Electromechanical Devices Pacific Biomedical Instruments June 2016 - May 2018 Oceanside, CA Supported regulatory maintenance and United States submissions for electromechanical medical devices, building practical expertise in FDA requirements, product life cycle activities, registration management, change assessment, labeling review, and audit preparation. Compiled 510(k) sections, device records, labeling, testing summaries, and administrative forms under senior review. Assessed engineering and supplier changes, routing higher risk decisions for senior regulatory review. Maintained establishment registrations, product registrations, renewal calendars, correspondence, and submission archives. Reviewed product documents against approved labeling and regulatory records, resolving discrepancies with stakeholders. Organized traceable regulatory evidence and tracked audit requests through documented closure. Supported product life cycle activities while developing practical judgment across FDA submission requirements. PROJECTS Robotic Surgical Platform Submission Strategy 2024 Connected regulatory strategy with software, cybersecurity, risk management, testing, labeling, clinical evidence, and FDA submission planning for a robotic surgical platform. Global Medical Device Technical File Program 2022 Coordinated technical documentation, change assessments, registrations, renewals, and audit evidence for connected electromechanical medical devices. LEADERSHIP & AWARDS Regulatory Affairs Certification, Devices, earned 2021 Led cross functional FDA meeting preparation recognized for clear strategy and disciplined follow through. Selected as regulatory subject matter expert for robotic surgery software and cybersecurity decisions. EDUCATION Master of Science in Regulatory Science University of Southern California GPA: 4.0 2018 Los Angeles, CA Coursework: FDA regulation, medical device submissions, clinical research, quality systems Bachelor of Science in Biomedical Engineering University of California, Irvine GPA: 4.0 2016 Irvine, CA Coursework: Medical device design, biomechanics, systems engineering, biological materials CERTIFICATIONS Regulatory Affairs Certification, Devices 2021 FDA Medical Device Regulatory Affairs Certificate 2020 TECHNICAL SKILLS FDA Submission Pathways: Q submissions, IDE, De Novo, 510(k) Medical Device Regulations: FDA regulations, FDA guidance, United States market access Device Safety Standards: IEC 60601 series, ISO 10993 1, essential performance Software Compliance: FDA software requirements, software documentation, software validation Cybersecurity Controls: FDA cybersecurity requirements, threat assessment, security evidence Risk Management: Risk analysis, risk files, design risk assessment Technical Documentation: Device descriptions, technical files, submission dossiers Product Life Cycle: Change assessments, Letters to File, sustaining activities Market Maintenance: Registrations, renewals, labeling control Health Authority Engagement: FDA meetings, briefing packages, agency correspondence Quality And Audits: Quality system audits, traceability, audit readiness Medical Device Systems: Robotic surgery, vision systems, connected platforms SKILLS Regulatory strategy FDA submissions 510(k) IDE De Novo Q submissions Risk management Cybersecurity Medical devices Robotic surgery Software systems Health authority meetings Regulatory writing Life cycle management Cross functional leadership PROFESSIONAL AFFILIATIONS Regulatory Affairs Professionals Society, medical device regulatory community Association for the Advancement of Medical Instrumentation, device standards community LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST

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