Gregg V. Email & Phone Number

United States

Boston, Ma, Us

MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.

Santa Clarita, Ca, Us

► Developed harmonized enterprise-wide risk management system to align methods for identifying, evaluating and managing safety, security, compliance and business risks across the organization.► Developed strategy to align risk management process with EN ISO 14971:2019 and EU MDR 2017/745.► Led risk management activities for three next-generation product lines.► Led design verification activities for a next-generation product line.► Developed post-market risk management surveillance system including data collection, analysis and reporting per ISO 14971, FDA and EU MDR requirements.

Brea, California, Us

► Developed risk management remediation strategy to ensure conformance to EN ISO 14971:2012.► Led risk management teams for next-generation product lines.► Led risk management post-market surveillance activities.

► Reporting to VP Quality, worked with senior leadership across the business to assess business need and gaps between current processes and future state system conforming to EN ISO 14971:2012, prioritized projects and managed teams to build a best-in-class risk management process.► Acquired talent and leveraged Lean Sigma expertise to build process and information systems; developed training program to train Quality and Engineering staff on state-of-the-art risk management and field action procedures for medical devices. ► Developed robust risk management and field action certification program.

► I was hired to lead a team to resolve an intractable problem around inefficient order processing. Used Six Sigma business analytics and kaizen to shrink processing time for past due orders by 50%. In the first three months of implementation, revenue increased by $1 million more than originally projected. ► Developed process validation certification program to enhance engineering skills in the R&D, Operations and Quality teams and improve regulatory compliance. ► Supported a 15-fold increase in production over 9 months through collaboration with stakeholders and applying kaizen and 5S events to optimize space utilization and process flow; reduced floor space 50% and eliminated 10 pallets of WIP weekly.► As change leader during a time of rapid growth, I transformed a unit from an environment of disengagement, lack of accountability, and broken processes to a high-performing, collaborative, team.

Minneapolis, Mn, Us

► I was hired to develop and deliver a clinical research training curriculum to enhance understanding of clinical research strategies and processes, business acumen and improve regulatory compliance. By the end of the first year, I had delivered over 40 training opportunities to a rapidly growing department.► Tasked with improving over 50 clinical processes, I led teams to map the clinical value stream and identify kaizen opportunities. At the end of the second year, the number processes had been trimmed by 25% and 6 kaizens had been completed.► Worked with the clinical safety team to speed processing of adverse event reporting. Reduced process steps by 30+% and overall lead time 4-fold.► Led the kaizens and managed implementation of numerous improvements "in-the-business" and "on-the-business" of clinical research project management. Developed a stage-gate process to help management better understand and control execution of multiple concurrent clinical trials and process improvement projects.

Duarte, Ca, Us

► I was hired to manage a complex research program investigating the roles of lipid-responsive nuclear receptors in regulating networks of gene expression in models of diabetes, heart disease and obesity.► Led cross-functional collaborations with Biostatistics, Microarray, Vivarium and other departments to identify target genes of nuclear receptors and drug candidates that activate gene transcription in models of obesity, diabetes and heart disease.► Managed and mentored research associates and interns in methods and techniques of drug discovery science.

Los Angeles, Ca, Us

► I was hired to manage operations of a major physiology laboratory, including budgeting and procurement.► My doctoral research program investigated intestinally-derived signals regulating the physiologic response to insulin insensitivity in various models of obesity and diabetes.

I was hired to design, execute and publish clinical trials of a novel, nutrient-based therapy targeted to improve food and drug absorption in patients with rapid gastrointestinal transit suffering from maldigestion and malabsorption.

Phd, Physiology & Biophysics

Ms, Human Nutrition

Bs, Chemistry; Bs Mathematics