Kendal Dinsmore

VP, Regulatory Affairs & Quality Assurance

UpDoc

Mar 2025 - Current (1 year 7 months)

VP, Regulatory Affairs & Quality Assurance

Mahana Therapeutics

Sep 2019 - Aug 2024 (5 years)

Part of the Senior Management Team and Foundational department member for a Software as a Medical Device (Mobile Apps) Digital Therapeutics company. Responsible for building up systems from scratch to scale for US and UK/EU territories.

Handled all aspects of quality regulatory system: ISO, MDR, FDA QSR, and Germany DiGA building out a risk appropriate system that integrates with coworkers day to day tasks.

Achieved ISO 13485 & ISO 27001 Certifications, De novo grant, MDR Class I and 510(k) Class II clearance.

Responsible oversight of several areas for the company: Clinical Operations, Customer Support, Medical Affaits, Cybersecurity, Compliance

C

Sr. Director, Quality Assurance

Counsyl Myriad Womens Health

Oct 2016 - Jun 2019 (2 years 9 months)

Oversee the Quality department and practices to create a site wide fully burdened quality management system. Establish Quality team and foster best practices for an advanced biotech with extremely modern testing systems in software and hardware automation in an aggressive change mode.

Develop, deploy, monitor and continuously improve upon all aspects of Quality Management System under the guidelines of a Clinical Diagnostics Laboratory Developed Test service model while maintaining the ability to quickly implement to any regulatory paradigm.

Owner of EH&S and responsible for establishing and maintaining CAL OSHA compliance, all federal, state and local regulations concerning employee and product safety, management of

S

Sr. Director Quality Assurance and Regulatory Affairs

Specific Technologies

Feb 2016 - Jan 2017 (1 year)

Hired to found the QARA department in a biotechnology medical device start up. Report to the COO. Responsible for building QMS throughout the organization in accordance with FDA QSRs and ISO13485. Responsible for regulatory oversight, submissions and design history file.

Direct project, strategic and tactical management over the establishment of an outsourced manufacturing line of high dimensional sensor arrays under AS9103 guidelines from scratch.

Director, Quality Assurance and Regulatory Affairs

Complete genomics Inc

Jan 2010 - Jan 2016 (6 years 1 month)

Responsible for building the Quality department from scratch and developing Quality infrastructure throughout the organization in accordance with relevant ISO or cGXP standards.

Strategically Plan and tactically execute quality planning to bring the company from a development / start-up state to a fully mature operations facility.

Develop, deploy, monitor and continuously improve upon all aspects of a fully implemented Quality Management System.

Manage site global regulatory for: Design, development, transfer, associated submissions and compliance for products and services needing medical device and IVD regulatory requirements.

Support site in developing best practices in Global Regulatory, Quali

I

Quality-Regulatory Manager

InSound Medical Inc

May 2006 - Apr 2009 (3 years)

Hired and developed team of 7 employees for medical device start up company, company management representative for regulatory compliance and report directly to CEO. In charge of planning and implementing an ISO 13485:2003 compliant quality systems for site. Initiated and obtained California state manufacturing license for medical devices. Have responsibility for all regulatory, internal and supplier audits. Hold fiscal responsibility for the department. Established, scheduled and lead quarterly management reviews. Train departments in design control, CAPA, Root Cause Analysis and cGMP standards. Strategic planning for continuous improvement and tactical daily functions.
Handle 510(k) submissions and regulatory guidance for new projects

H

Quality Assurance Manager

Hitachi Chemical Diagnostics

Jan 2002 - May 2006 (4 years 5 months)

Hired and developed team of 10 employees, report to Director of QA/RA. In charge of document control for site and helped develop new NCR/CAPA. Responsible for internal and supplier audits. In charge of department finances and budget. Responsible for ISO13485: 2003 compliance, site validations and protocols. Implemented on site SPC software for real time statistical analysis. Train new clients on the CLA-1 allergy screening system at client site. Implement ongoing training program for new customers, including developing a 360-degree feedback loop after initial client training. Successfully led multi-functional teams focused on cost cutting, process improvements and safety, saving $85k a month to bottom line. Led strategic implementation of o

B

Director of Quality Control / Safety Manager

Biozone LaboratoriesPitsb

Oct 1998 - Aug 2001 (2 years 11 months)

Senior management team member and reported directly to president; managed staff of 6.
Released raw materials, reviewed product specifications prior to launch. Created SOP's
for department. Wrote and performed cleaning validations. Investigated non-conforming
materials. Managed Cal-OSHA relationship. Worked with FDA 483 issues. Audited raw
material suppliers. Implemented product stability program, extending product life from 3
to 12 months.

S

Microbiologist, Quality Control

Sees Candies Inc

Dec 1995 - Jan 1998 (2 years 2 months)

Reported to Quality Control Manager and supervised 3 employees. Implemented a new
microbiological method for speciation of bacteria and a new API speciation system to
identify potentially harmful bacteria. Tested and released raw materials, in-process and
final products for microbiological safety. Managed customer complaints. Performed
supplier audits.

About

Detail

Timeline

Résumé

Kendal Dinsmore

About

Detail

Behavioral traits