Head Of Quality & Regulatory
CurrentObtained ISO 13485 CertificationRemediated quality systemsDeveloped worldwide regulatory strategies
Jun 2023 - Present
AeroLeads people directory · profile
Grant Palmer Email & Phone Number
Quality/Regulatory Executive
at
Electrogenics Laboratories Limited
1 work email found
@grant-palmer.com
1 phone found area 818
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Quality/Regulatory Executive
Location
Burbank, California, United States
Who is Grant Palmer? Overview
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Quick answer
Grant Palmer is listed as Quality/Regulatory Executive at Electrogenics Laboratories Limited, based in Burbank, California, United States. AeroLeads shows a work email signal at grant-palmer.com, phone signal with area code 818, and a matched LinkedIn profile for Grant Palmer.
Grant Palmer previously worked as Head of Quality & Regulatory at Electrogenics Laboratories Limited and Quality, Regulatory, R&D and Operations Consultant at Consultant. Grant Palmer holds Be, Engineering from University Of Sydney.
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{first}{last}@grant-palmer.com
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Profile bio
About Grant Palmer
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
Listed skills include Medical Devices, Fda, Quality System, Validation, and 46 others.
Current workplace
Grant Palmer's current company
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19 roles
Grant Palmer work experience
A career timeline built from the work history available for this profile.
Quality, Regulatory, R&D And Operations Consultant
Current
Consultant
EU/MDR RemediationRisk assessment development and reviewDesign reviewQuality system planningRegulatory strategiesUDI consultation
Oct 2021 - Present
Consultant Vp Quality & Regulatory
Current
Confidential Startup In Diagnostics Space
Created regulatory strategyOutlined QMSRisk management file creation & risk analysis generation
Jun 2020 - Present
Consultant Mdr Post-Market Surveillance Remediation
Large Multi-National In The Ophthalmology Space
Remediation of MDR post-market surveillance findings, creation of PMS documentation & updates to risk management file
Sep 2021 - Feb 2022
Vice President, Quality And Regulatory
Successful 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.
Jun 2020 - Sep 2021
Vice President Quality Assurance, Regulatory & Clinical Affairs
Responsible 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.
Apr 2019 - Jun 2020
Director Quality Assurance Regulatory Affairs
Aug 2018 - Mar 2019
Vice President, Quality, Regulatory & Pilot Production
Rebuilt 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.
May 2011 - Aug 2018
Regulatory Affairs Consultant
Aubrey Group
Managed client submissions to FDA.Guided and advised clients on regulatory strategy.
Jun 2010 - May 2011
Consultant Vp Research & Development
A Dialysis Company
Designed 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.
Mar 2009 - May 2011
Quality, Regulatory, R&D And Operations Consultant
Freelance
Risk 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
Jun 2008 - May 2011
Principal
Triquetra Services
R&D, Clinical, Regulaity and Quality Assurance for the biotech industry.
Mar 2008 - May 2011
Quality/Regulatory Consultant
A Gastric Device Company
Created hazard and risk files for compliance.
Mar 2009 - Jun 2009
Director Clinical/Reg Affairs, Wearable R&D
Xcorporeal Inc
Responsible for clinical research, program management and the R&D wearable artificial kidney program.
Mar 2007 - Mar 2009
Director, Clinical Affairs
Second Sight Medical Products
As 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.
Jul 2005 - Mar 2007
Director, Clinical, Regulatory And Quality
Supervised 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.
Oct 2002 - Jul 2005
Acting Director/Senior Manager
Responsible 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.
Dec 1998 - Sep 2002
May 1997 - Dec 1998
Manager Clinical Affairs
Provided 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.
Dec 1990 - May 1997
3 education records
Grant Palmer education
Be, Engineering
University Of Sydney
Bsc, Physics, Computer Science
University Of Sydney
Education record
James Ruse Ahs
FAQ
Frequently asked questions about Grant Palmer
Quick answers generated from the profile data available on this page.
What company does Grant Palmer work for?
Grant Palmer works for Electrogenics Laboratories Limited.
What is Grant Palmer's role at Electrogenics Laboratories Limited?
Grant Palmer is listed as Quality/Regulatory Executive at Electrogenics Laboratories Limited.
What is Grant Palmer's email address?
AeroLeads has found 1 work email signal at @grant-palmer.com for Grant Palmer at Electrogenics Laboratories Limited.
What is Grant Palmer's phone number?
AeroLeads has found 1 phone signal(s) with area code 818 for Grant Palmer at Electrogenics Laboratories Limited.
Where is Grant Palmer based?
Grant Palmer is based in Burbank, California, United States while working with Electrogenics Laboratories Limited.
What companies has Grant Palmer worked for?
Grant Palmer has worked for Electrogenics Laboratories Limited, Consultant, Confidential Startup In Diagnostics Space, Large Multi-National In The Ophthalmology Space, and Bluewind Medical.
How can I contact Grant Palmer?
You can use AeroLeads to view verified contact signals for Grant Palmer at Electrogenics Laboratories Limited, including work email, phone, and LinkedIn data when available.
What schools did Grant Palmer attend?
Grant Palmer holds Be, Engineering from University Of Sydney.
What skills is Grant Palmer known for?
Grant Palmer is listed with skills including Medical Devices, Fda, Quality System, Validation, Iso 13485, Cross Functional Team Leadership, Quality Assurance, and Regulatory Affairs.
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