Grant Palmer Email and Phone Number
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Senior-level medical device development professional with wide therapy area experience and proven track record of applying appropriate and practical methodologies that meet business needs while minimizing risks. Motivated achiever with demonstrable ability to recommend enhancements to business processes.Outstanding project manager who coordinates communications, information, and highly skilled professionals to meet technology needs and evaluate progress while assuring smooth, efficient projects and activities.Strong interpersonal, written, and verbal communicator who can deliver effective presentations, consult on technology projects, and maintain collaborative relationships.Exceptional problem-solver with keen ability to resolve technology issues, define regulatory strategies, analyze business processes for improvement, utilizing understand across a wide range of regulatory, engineering and therapeutic areas.Accomplishments: - Generated 510(k), PMA and Technical File documentation, for Class I , II and III devices including pacemakers, dialysis devices, internet attached devices, and implantable bioabsorbable materials- Successful remediation of quality and clinical systems following adverse audit findings across a range of company sizes and therapeutic areas - Implementation and upgrade of ISO 13485 Quality Systems- Created device recall advisory team who provided medical, statistical, and ethical guidance which resulted in significant reductions in audit findings and praise from the FDA- Successfully managed large and small departments, with close adherence to timelines and budgetAreas of Expertise: - Development of advanced Class I, II and III medical devices - FDA Regulations and CE Mark - Global design, regulatory and clinical strategy development - FDA and CE submissions, including IDEs, 510(k)s & PMAs - Building of strong and efficient departments, leveraging strategy, policies, and SOPs - Preparation of creative development plans for product approvals, which support corporate objectives & goals - Design, direction and successful execution of clinical trials - Management all elements of ISO/QSR requirements for to medical device design and manufacturing. - Remediation and integration of quality systems - FDA/Notified Body regulatory inspections and negotiations - Experienced in start-up, early stage and established companies developing a wide variety of medical devices, including implantable devices - Operations for clinical/market launch builds & transfer to manufacturing - Public speaking and staff training
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Head Of Quality & RegulatoryElectrogenics Laboratories Limited Jun 2023 - PresentNorth Sydney, Nsw, AuObtained ISO 13485 CertificationRemediated quality systemsDeveloped worldwide regulatory strategies
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Quality, Regulatory, R&D And Operations ConsultantConsultant Oct 2021 - PresentEU/MDR RemediationRisk assessment development and reviewDesign reviewQuality system planningRegulatory strategiesUDI consultation
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Consultant Vp Quality & RegulatoryConfidential Startup In Diagnostics Space Jun 2020 - PresentCreated regulatory strategyOutlined QMSRisk management file creation & risk analysis generation
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Consultant Mdr Post-Market Surveillance RemediationLarge Multi-National In The Ophthalmology Space Sep 2021 - Feb 2022Remediation of MDR post-market surveillance findings, creation of PMS documentation & updates to risk management file
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Vice President, Quality And RegulatoryBluewind Medical Jun 2020 - Sep 2021Park City, Utah, UsSuccessful negotiation with FDA to full IDE approvalRemediation of Quality System with correction of major deficienciesPlanning and implementation of MDR quality systemLeading the quality and regulatory functions for a start-up with an innovative neurostimulation implant.Global strategic direction for quality and regulatory.Oversee preparation & filing of regulatory documents. Successful submissions for reductions of clinical trial sample size and biocompatibility questions.Ensure compliance with US and international regulations. -
Vice President Quality Assurance, Regulatory & Clinical AffairsBruin Biometrics, Llc Apr 2019 - Jun 2020Los Angeles, California, UsResponsible for all Quality Assurance, Regulatory Affairs and Clinical Research activities.Remediation of Quality System with correction of major deficienciesImplementation of electronic document control system.Preparation of QMS for EU MDR.Oversee preparation & filing of regulatory documents.Oversee clinical affairs operations.Direct the development of quality systems.Ensure compliance with US and international regulations. -
Director Quality Assurance Regulatory AffairsBruin Biometrics, Llc Aug 2018 - Mar 2019Los Angeles, California, Us
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Vice President, Quality, Regulatory & Pilot ProductionSparton Corporation May 2011 - Aug 2018De Leon Springs, Florida, UsRebuilt a 13485 Quality System from the ground up, whilst maintaining compliance under the existing system.Developed successful 510(k)s and other submissions for clients.Corporate resource for client regulatory issues.Successfully led FDA, ISO 13485 and ISO 9001 audits.Added ISO 9001 to the company's portfolio.Simplified methods to maintain compliance with lower overhead.Developed Quality Systems for deployment by clients.Successfully consulted with clients to achieve FDA clearance/approval for new products.Oversees manufacturing transfer and initial pilot production activities. -
Regulatory Affairs ConsultantAubrey Group Jun 2010 - May 2011Managed client submissions to FDA.Guided and advised clients on regulatory strategy.
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Consultant Vp Research & DevelopmentA Dialysis Company Mar 2009 - May 2011Designed and developed a functional portable, home-based prototype dialysis device utilizing a small 4 person team in 3 months.Developed a patent portfolio for additional dialysis treatment methodologies. Developed methods for simplifying dialysis set-up & delivery.
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Quality, Regulatory, R&D And Operations ConsultantFreelance Jun 2008 - May 2011Risk assessment development and reviewQuality and regulatory remediationProgram management for medical devices including a novel dialysis deviceSuccessful development, submission and negotiation of 510(k)s for client devices including implantable, bioabsorbable materialsProduct development & prototyping
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PrincipalTriquetra Services Mar 2008 - May 2011R&D, Clinical, Regulaity and Quality Assurance for the biotech industry.
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Quality/Regulatory ConsultantA Gastric Device Company Mar 2009 - Jun 2009Created hazard and risk files for compliance.
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Director Clinical/Reg Affairs, Wearable R&DXcorporeal Inc Mar 2007 - Mar 2009Responsible for clinical research, program management and the R&D wearable artificial kidney program.
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Director, Clinical AffairsSecond Sight Medical Products Jul 2005 - Mar 2007As part of the senior management team, directed international clinical studies to support research, and product development programs for a novel device technology to restore sight to the blind.Presented to the general public at the Braille Institute and the Foundation for Fighting Blindness to increase awareness of the program; and incorporated procedures to protect vulnerable population.Evaluated comparable technology strategic for merger/acquisition.Supervised in-house and field staffDeveloped clinical/regulatory strategy for a novel sight restoration technology through direct pre-IDE interactions with FDA and key opinion leadersPresented to patient advocacy groups an scientific committeesDeveloped and trained international and domestic researchers in implant surgery and follow-up
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Director, Clinical, Regulatory And QualityAlsius Oct 2002 - Jul 2005UsSupervised quality managers, engineers and receiving personnel, as well as field clinical staffTrained sales force on technology useCreated post-market study and support systems for the CoolGard SystemPerformed field service in EuropeResponsible for generating 510(k) documentation, clinical/regulatory strategy and quality system reporting, including MDR and MDV for the CoolGard, Cooline, Icy and FortiusLed internal team for FDA and Notified Body inspections -
Acting Director/Senior ManagerBoston Scientific Dec 1998 - Sep 2002Marlborough, Ma, UsResponsible for clinical and pre-clinical research. Managed department of 16, including four Clinical Project Managers.Created a team of advisors to provide guidance during product recall.Supervised annual departmental budget of $4-6M.Provided clinical review for merger/acquisition.Implemented systems increasing overall department efficiency.Negotiated a 25% reduction in CRO contract cost from $2.1M to $1.6M.FDA and French Health Authority meetings regarding AAA stent-graft recalls -
Senior Clinical ResearchBaxter May 1997 - Dec 1998Deerfield, Illinois, UsContributed to FDA approval of an implantable artificial heart. -
Manager Clinical AffairsTelectronics Pacing Systems Dec 1990 - May 1997Provided strategic and managerial leadership for global medical device trials, marketing trials and research for pacemakers, implantable defibrillators and cardiomyoplasty devices.On-call service to provide physicians and other field staff with information and guidance during device malfunctions. Responsible for coordinating efforts of hardware and software analysis and for communicating to the field.Managed foreign clinical research sites, including, site initiation, training, logistics and compliance for Southern and Eastern Europe while living in France. Engineering design responsibility for Clinical Validation Department, including software development and analysis. Designed training courses in preparation for first human use.
Grant Palmer Skills
Grant Palmer Education Details
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University Of SydneyEngineering -
University Of SydneyComputer Science
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James Ruse Ahs
Frequently Asked Questions about Grant Palmer
What company does Grant Palmer work for?
Grant Palmer works for Electrogenics Laboratories Limited
What is Grant Palmer's role at the current company?
Grant Palmer's current role is Quality/Regulatory Executive.
What is Grant Palmer's email address?
Grant Palmer's email address is gr****@****mer.com
What is Grant Palmer's direct phone number?
Grant Palmer's direct phone number is +181885*****
What schools did Grant Palmer attend?
Grant Palmer attended University Of Sydney, University Of Sydney, James Ruse Ahs.
What are some of Grant Palmer's interests?
Grant Palmer has interest in Civil Rights And Social Action, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Arts And Culture.
What skills is Grant Palmer known for?
Grant Palmer has skills like Medical Devices, Fda, Quality System, Validation, Iso 13485, Cross Functional Team Leadership, Quality Assurance, Regulatory Affairs, R&d, Product Development, Biotechnology, Design Control.
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