Robin F. Martin Email and Phone Number
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Regulatory Affairs professional with over 12 years of medical device submission experience. Comprehensive understanding of global regulatory landscape and a demonstrated record of over 15 successful FDA submissions, including 510(k)s, PMA supplements and IDEs. Experience in EU MDR and IVDR remediation. Exposure to regulatory and clinical requirements for a diverse array of medical products: injectable implants, combination drug / device product, anesthesia and monitoring equipment, diagnostic imaging systems (MRI, PET/MR & ultrasound), post-processing applications, maternal / infant care products, and medical device software applications.Highly motivated, detail-oriented, strategic thinker with an exceptional track record of aligning and prioritizing tasks to meet business needs.Education: Biomedical Engineering (BS), Master of Business Administration (MBA) Expertise in:• Leading global regulatory and clinical strategy development, as well as pre-submission meeting. • Experience with Good Clinical Practices (GCP) / ISO 14155 and Quality System Regulations (QSR) / ISO 13485, MDSAP and EU MDR. • Execution of global premarket registrations (Brazil, Canada, China, European Union, Japan, U.S., etc.) and clinical trial applications. • Review of medical device promotional material for consistency with regulatory filings.• Navigation of changing regulatory environment and effective communication of changing global regulations to development teams.
Kinetic Compliance Solutions, Llc
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Co-Founder & Chief Regulatory StrategistKinetic Compliance Solutions, Llc Apr 2016 - PresentMilwaukee, Wisconsin, UsObtained 510(k) clearances for ambulatory ECG devices, multi-modality diagnostic imaging feature and dosimetry system. Evaluated regulatory classification and pathways for novel medical devices. Developed and implemented regulatory procedures at mid-size medical device manufacturer. Development of global regulatory strategies and registrations for a variety of medical devices. MDSAP / ISO / Notified Body audit support. Provide guidance on EU MDR / IVDR remediation strategies and develop compliant technical documentation. Successful pre-submission and meeting with FDA. Regulatory services for medical device companies with a specific focus on market access in the U.S., Canada and EU. Partner with a broad range of companies (from emerging to mature) and investors to support regulatory strategies, revenue generation and market access. www.kineticcompliance.com
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Regulatory Affairs Director - ClinicalGe Healthcare Dec 2014 - Dec 2015Chicago, UsEstablish global clinical strategies for ultrasound, monitoring, anesthesia, diagnostic imaging systems (MRI, PET/MR and ultrasound). Communicate impact of changing global clinical trial regulations and inform regulators of reportable events. Select accomplishments:• Ensure compliance with GCP / ISO 14155 for up to thirty concurrent company-sponsored clinical research studies. • Provide key significant contributions to revisions of adverse event reporting procedure, clinical trial protocol template, and public registry guidance. -
Regulatory Affairs ManagerGe Healthcare Jun 2013 - Dec 2014Chicago, UsObtained and maintained global approvals for software applications, device accessories, MRI and PET/MR systems. Set strategy for newly developed technology including pharmaceutical manufacturing equipment. Conduct internal audits to 21 CFR 820 and ISO 13485.Select accomplishments:• Executed 510(k) submission for GE’s first PET/MR system; obtained market clearance in less than four months.• Achieved successful global submissions (Brazil, Canada, China, EU, Japan, etc.) based on identification of key markets and provided regulatory expertise in associated audits. • Led cross-functional team in FDA pre-submission meeting and submission responses for quick resolution on registrations.
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Regulatory Affairs LeaderGe Healthcare Jul 2009 - May 2013Chicago, UsGained and sustained global premarket registrations for patient monitoring equipment (blood pressure, central station, etc.), as well as MRI equipment. Select accomplishments: • Obtained MRI 510(k) clearance with no FDA questions for promotion of new product features at Radiological Society of North America (RSNA) trade show in 2011. • Reviewed promotional materials to ensure consistency with regulatory submissions.• Selected to assist central businesses in remediation effort for aging clinical trials.
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Regulatory Affairs SpecialistMerz Aesthetics (Formerly Bioform Medical, Inc.) Jan 2008 - Jun 2009Managed changes to two premarket approvals (PMAs) and more than ten 510(k) product files, technical files, design dossiers, and Canadian licenses for sterile injectable dermal filler. Provided support for newly acquired technology, including combination (device / drug), animal tissue derivative and electrical ablation devices. Conducted internal audits to 21 CFR 820 and ISO 13485. Conducted literature evaluations to support regulatory fillings.Select accomplishments: • Supported U.S. Class III products by writing and submitting 10+ PMA supplements and annual reports.• Created statistical analysis plans and wrote clinical summaries based on approved clinical protocols for 180-day PMA supplements and post-approval study.
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Research & Development EngineerMerz Aesthetics (Formerly Bioform Medical, Inc.) Jun 2006 - Jan 2008Performed research and design in conjunction with the development of new products for market introduction. Conducted design verification and validation activities as well as process validations. Select accomplishments:• Designed syringes and needles, using novel materials and completed all aspects of development, from documentation to bench and clinical testing, as well as soliciting user feedback.• Wrote protocols and reports associated with risk assessments, installation qualifications (IQ), operational qualifications (OQ), and testing of new or changed products.
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Internship - R&D Engineer Interventional CardiologyBoston Scientific Corporation May 2005 - Aug 2005Marlborough, Ma, UsWorked with principal scientist and engineers in drug-eluting stent coatings group.Select accomplishment:• Completed various verification tests for ongoing studies in accordance with quality system procedures. -
Internship - R&D EngineerFda Jan 2004 - Apr 2004Silver Spring, Md, UsSelected to attend Les Aspin Center and work at Center for Devices and Radiological Health (CDRH) while completing undergraduate coursework.Select accomplishment:• Researched process by which unwanted calcification in porcine heart valves occurs.
Robin F. Martin Skills
Robin F. Martin Education Details
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Marquette UniversityBusiness Administration -
Marquette UniversityBiomedical Engineering
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Depere
Frequently Asked Questions about Robin F. Martin
What company does Robin F. Martin work for?
Robin F. Martin works for Kinetic Compliance Solutions, Llc
What is Robin F. Martin's role at the current company?
Robin F. Martin's current role is Co-Founder & Chief Regulatory Strategist l Regulatory Consultant l Health Technology.
What is Robin F. Martin's email address?
Robin F. Martin's email address is rf****@****ail.com
What schools did Robin F. Martin attend?
Robin F. Martin attended Marquette University, Marquette University, Depere.
What skills is Robin F. Martin known for?
Robin F. Martin has skills like Medical Devices, Fda, Regulatory Affairs, Iso 13485, Quality System, Cross Functional Team Leadership, Regulatory Requirements, Validation, Design Control, Clinical Trials, Clinical Research, U.s. Food And Drug Administration.
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