Regulatory Affairs Specialist in Orange, California at KaVo Kerr

Date Posted: 7/30/2019

Job Snapshot

Job Description

Job ID: KAV004196

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


This position is responsible for assisting in the preparation and submission of global product registrations. The candidate must have a foundation and basic working knowledge of global medical device regulations, including 510k and international registration dossier submissions. 

Essential Duties and Responsibilities: 
  • Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance.  This includes, but is not limited to, 510ks, international dossiers and CE technical files
  • Regional liaison between local dealers and Corporate Global RA
  • Work alongside commercial team to build RA strategy for projects for alignment
  • Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, KSA, Health Canada, etc..
  • Support domestic and international field corrective actions and adverse event reporting
  • Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management
  • Perform special projects as needed
  • Scope: Global product registrations

Job Requirements


Education and Experience:
  • Bachelor's Degree (BA/BS) from four-year college/university or combination of education and Regulatory Affairs experience
  • 2+ years of Regulatory Affairs experience and basic working knowledge of global medical device regulations, including 510k and international registration dossier submissions. 

  • Ability to work in a team-oriented environment and is able to meet tight deadlines.  Building internal working relationships with all department levels.  In the discretion of RA management, handles routine interactions with FDA, Health Canada, Notified Bodies and other regulatory agencies.
  • Minimal experience in adverse event reporting and/or field corrective actions preferred.
  • Excellent written and oral communication skills. Strong analytical and organizational skills; ability for detail and precision.  Team player with ability to work independently.
  • Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.  
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Computer literate in Word, Excel and PowerPoint

Physical Demands:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. 
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually moderate.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at:


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.