Grant Palmer

Background

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 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 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