Regulatory Affairs Specialist in Orange, California at KaVo Kerr

Date Posted: 6/7/2019

Job Snapshot

Job Description

Job ID: KAV004118

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.



Description

Position Overview:
The Regulatory Affairs (RA) Specialist assists, evaluates and completes domestic and/or international regulatory tasks related to the following: submissions (US, CA, ROW), EU technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. This individual is responsible for obtaining regulatory clearances based on company objectives, attending product development meetings, project meetings; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.

Essential Duties and Responsibilities: 
  • Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company
  • Assists and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Technical writing of procedures and/or SOPs 
  • Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects 
  • Submission experience with US FDA 510k’s, Health Canada Medical Device License, EU notification experience
  • Assists with regulatory strategies and ensures timely submissions (510s, 513G, device licenses) of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and changes to existing products. 
  • Support UDI and GUDID database operations
  • Responsible for FDA requests to ensure customs/trade compliance
  • Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body
  • EU Technical file experience and knowledge of MDD requirements and exposure to the upcoming MDR
  • Coordinates, prepare and maintains facility registrations, establishments, etc..
  • Maintains clearances within the product registration software system (Register)
  • Assists with reviewing product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations (change management) 
  • Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management
  • Perform special projects as needed

Scope: Domestic and International (when applicable)

Supervisory Responsibilities: This job has no supervisory responsibilities

Job Requirements



Qualifications

Requirements:
  • Bachelor's Degree (BA/BS) from four-year college/university or combination of education and Regulatory Affairs experience
  • 4+ years of Regulatory Affairs experience
  • Must have EU Technical file experience and knowledge of MDD requirements and exposure to the upcoming MDR

Preferred Skills:
  • Medical Device experience preferred
  • Strong analytical and organizational skills; ability for detail and precision
  • Team player with ability to work independently
  • Excellent written and oral communication skills
  • Project management skills 
  • Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages
  • Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner
  • Strong computer skills in Word, Excel and PowerPoint
  • Ability to work under minimal supervision
  • Advanced degree or RAC certification 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.

#LI-CY1

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.