Regulatory Affairs Specialist in Orange, California at Danaher

Date Posted: 6/7/2019

Job Snapshot

Job Description

Job ID: KAV004117

About Us

The Dental Platform will become an independent publicly traded company by way of an initial public offering with an anticipated completion in the second half of 2019.  “Dental Co” will become one of the largest and most innovative dental companies in the world.  We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).


Description

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

Supervisory Responsibilities: This job has no supervisory responsibilities.

Job Requirements



Qualifications

Requirements:
  • Bachelor's Degree (BA/BS) from four-year college/university or equivalent combination of education and Regulatory Affairs experience
  • 1+ years of Regulatory Affairs experience

Preferred Skills/Experience:
  • Medical Device experience preferred
  • 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.

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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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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.