Summary
Overview
Work History
Education
Skills
Key Qualifications
Affiliations
Certification
Timeline
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Karen Kakunes

Herriman,UT

Summary

Corporate executive with robust experience in driving business transformations and operational improvements. Known for delivering strategic initiatives that foster growth and enhance profitability. Exceptional at fostering collaborative environments and adapting to dynamic business needs.


Overview

30
30
years of professional experience
1
1
Certification

Work History

Sr. Vice President Quality Assurance and Regulatory Affairs

Ultradent Products, Inc.
01.2023 - Current
  • Provide strategic leadership and guidance to ensure compliance with global regulations and standards that align with corporate objectives and maintain the company’s position as a trusted leader in the dental industry
  • This position has responsibility and authority for personnel who manage, perform, and assess work affecting regulatory and quality, while ensuring they have the independence and authority to perform within their roles
  • Additional roles include Organizational Official of internal Institutional Review Board

Sr. Director Quality Assurance and Regulatory Affairs

Ultradent Products, Inc.
06.2021 - 01.2023
  • Responsible for ensuring global regulatory and quality system requirements are effectively established and maintained with regulations, standards, and directives and are consistent with corporate objectives
  • This position has responsibility and authority for personnel who manage, perform, and assess work affecting regulatory and quality, while ensuring they have the independence and authority to perform within their roles
  • Additional roles include Chair of Evaluation Review Board

Regulatory Affairs Director

Ultradent Products, Inc.
05.2020 - 06.2021
  • Responsible for all global regulatory with direct oversight of 7 Regulatory Affairs Specialists who support company product registrations, both pre- and post-market
  • Register or support registration through planning for new product development and regulatory assessment of product changes
  • Direct involvement and planning for company objectives and key results

Regulatory Affairs Manager

Ultradent Products, Inc.
01.2016 - 05.2020
  • Supervision and mentorship of RA Specialists I – III and Regulatory Affairs Associates
  • Submission and clearance of 510(k)s for new products (equipment, chemical)
  • Preparation, submission, and successful approval of medical device technical documentation for Class I and IIa medical device products with EU Notified Body
  • Preparation and submission of Cosmetic product dossier(s) for EU
  • Preparation, submission, and approval of Medical Devices, Cosmetics, and Natural Health Products (NHP) with Health Canada
  • Oversight of international regulatory team and regulatory global strategy
  • Department budgeting
  • Biocompatibility and biocompatibility test method planning and approval
  • Clinical Evaluation planning, research, and preparation of documentation
  • Active participant in audits at federal and international levels: MDSAP, FDA medical device and drug, ISO 13485, Anvisa, MHLW, Health Canada, Korea, private label manufacturers
  • Class II and III recalls of foods, cosmetics and medical devices
  • US and International vigilance reporting
  • Review of OTC drug, medical device and cosmetic labeling for domestic and international markets
  • Electronic update of medical device and drug registrations and listings
  • Creation and continuous improvement of processes related to design, regulatory, quality, etc

Sr. Regulatory Affairs Associate

Ultradent Products, Inc.
01.2008 - 01.2016
  • Responsible for the safety and efficacy of dental products as well as the clearance and registration in both domestic and international markets with focus on Canada, Japan, China, and Australia
  • Duties include, but are not limited to: Medical device 510(k) documentation and submission with FDA as well as listing of drug/device establishment(s) and drug/device product(s) with FDA
  • Creating and implementing US drug master files and EU cosmetic dossier files
  • Preparation of technical files for EU class I and IIa technical files which include determination and selection of biocompatibility testing to ISO 10993, conducting literature searches and writing clinical summaries to demonstrate safety and efficacy of new/existing products according to MEDDEV.2.7.1
  • Ensure that all labeling is concurrent to cosmetic, OTC drug, and medical device regulations
  • Regulatory specialist on risk management and product design and development teams
  • Regulatory consulting and support for multiple OEM customers

Quality Compliance Team Lead

Ultradent Products, Inc.
01.2005 - 01.2008
  • Scheduled and conducted internal audits according to cGMP, internal Quality Management System procedures, and federal and international regulations and guidelines
  • Responsible for writing and issuing audit reports with subsequent verification of actions taken to correct identified non-conformities
  • Scheduled and conducted external supplier cGMP audits
  • Participate in FDA, MHRA, MHLW, Notified Body, and customer audits with responsibility to provide written response to non-conformities and verify actions taken to correct findings
  • CAPA system management
  • Employee supervision and mentoring in the areas of complaints, batch records, and corrective and preventive actions
  • Compose, implement, train, and maintain SOPs for managed areas and according to federal and international regulations

Batch Record Team Lead

Ultradent Products, Inc.
05.1995 - 01.2005
  • Reconciliation and traceability of chemical from raw material to finished goods
  • Created, updated, and maintained key documents in the Formulation department including but not limited to spreadsheets, formula sheets, SOPs, Raw Material Specification(s), etc
  • Purchasing of raw chemical
  • Digitized formulation documentation onto computer database
  • Employee supervision and mentoring in the areas of traceability, document control, DMRs, and cGMPs

Education

MBA -

University of Utah
Salt Lake City, UT
05-2024

Bachelor of Science - Nursing

Western Governor’s University
03-2017

Associate of Science - Nursing

Salt Lake Community College
Salt Lake City, UT
05-2011

Skills

  • Strategic leadership
  • Mergers and Acquisitions
  • Leadership and People Development
  • Executive Leadership
  • Regulatory Compliance
  • Policies and Procedures
  • Operational Excellence
  • KPI Tracking

Key Qualifications

  • Successfully lead large, cross-functional teams driving QA and RA initiatives aligned with global organizational goals. Developed and executed comprehensive quality strategies, aligning regulatory compliance with business objectives.
  • In-depth knowledge of global regulatory requirements, including but not limited to FDA, MDR, MDSAP, and other relevant regulations. Track record of ensuring compliance with cGMP (Good Manufacturing Practices) guidelines, quality standards (ISO), and relevant industry guidelines.
  • Expertise in developing, implementing and maintaining robust quality systems, including quality management systems (QMS), risk management processes, and validation methodologies. Proven ability to design and optimize processes to enhance efficiency and effectiveness while maintaining compliance.
  • Skilled at fostering collaboration and influencing stakeholders across diverse functions, including finance, R&D, clinical, operations, and marketing teams. Strong relationship building with regulatory agencies, including successful interactions with FDA, Notified Body, and other authorities.
  • Track record of implementing quality improvement initiatives, leveraging data analytics, metrics, and quality tools (such as Six Sigma and Lean methodologies) to drive process optimization, reduce defects, and enhance customer satisfaction.
  • Proven ability to lead and manage change initiatives, ensuring smooth transitions during organizational restructuring, mergers, acquisitions, or system implementations. Skilled in developing change management plans, communication strategies, and training programs.
  • Experience leading and participating in internal and external audits and inspections, ensuring adherence to regulatory requirements and addressing findings and observations in a timely and effective manner.
  • Strong people leadership skills, fostering a high-performance culture and developing talent within QA and RA teams. Skilled in coaching, mentoring, and providing professional development opportunities to promote career growth.

Affiliations

Regulatory Affairs Professionals Society

Certification

  • Registered Nurse License (RN) - State Board of Nursing.

Timeline

Sr. Vice President Quality Assurance and Regulatory Affairs

Ultradent Products, Inc.
01.2023 - Current

Sr. Director Quality Assurance and Regulatory Affairs

Ultradent Products, Inc.
06.2021 - 01.2023

Regulatory Affairs Director

Ultradent Products, Inc.
05.2020 - 06.2021

Regulatory Affairs Manager

Ultradent Products, Inc.
01.2016 - 05.2020

Sr. Regulatory Affairs Associate

Ultradent Products, Inc.
01.2008 - 01.2016

Quality Compliance Team Lead

Ultradent Products, Inc.
01.2005 - 01.2008

Batch Record Team Lead

Ultradent Products, Inc.
05.1995 - 01.2005

MBA -

University of Utah

Bachelor of Science - Nursing

Western Governor’s University

Associate of Science - Nursing

Salt Lake Community College

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Karen Kakunes