This site uses cookies. To find out more, see our Cookies Policy

Senior Regulatory Affairs Specialist in Brea, California at Ormco

Date Posted: 5/18/2019

Job Snapshot

Job Description

Job ID: ORM001600

About Us

Danaher's Dental Platform is a $3B global business focused on all aspects of dental care.  With the intention to spin-off the Dental Platform to become its own public company 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

Summary: This person will assume responsibility for the independent preparation and submission of international product registrations for ROW (rest of world) countries, including Canada. This person will also expected to participate in new product development meetings, activities and assume domestic registrations, such as 510ks.The scope of the submissions will be focused primarily on orthodontic products and devices.  Regulatory Affairs Senior Specialist will utilize understanding of regulations to help develop RA strategy for new products and design changes and prepare/submit regulatory filing.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Plans and prepares regulatory submission documents for US or OUS regulatory filings under minimal supervision.
  • Prepares documentation that is complete, accurate, and on time.
  • Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams. 
  • Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Participates in audits and inspections of the company and its quality systems.

Job Requirements



Qualifications

REQUIREMENTS:

  • Bachelor’s degree in a scientific discipline
  • 3-5+ years in RA role within Medical Device or Pharmaceutical industry

PREFERRED SKILLS:

  • Direct experience with preparing and submitting materials for 510(k), MDEL and/or CE marking.
  • Excellent knowledge and experience with global medical device regulatory requirements and product registrations.
  • Working knowledge of product development process.
  • Ability to identify, research, and analyze technical documentation and governmental regulations
  • Experience and knowledge in Software Medical Devices 
  • Strong communication skills both written and verbal. 
  • Experience working in cross-functional product development team

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.

#LI-MC1

IND-KAV1


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.