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Regulatory Affairs Manager in Orange, California at KaVo Kerr

Date Posted: 6/6/2019

Job Snapshot

Job Description

Job ID: KAV003794

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

JOB SUMMARY:
The Manager of Regulatory Affairs will provide leadership and management to RA staff.  Apply expert knowledge of EPA, FDA, Health Canada, EU Biocide and MDD/MDR regulatory requirements.  Develop and implement global regulatory strategies.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Develops RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
  • Responsible for product registrations, state licenses, and annual reports for Medical Device products globally, through interactions with International Sales Team, in-country business partners and Ministries of Health.
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Oversees maintenance of technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark and Biocide.
  • Supports audits and inspections of the company and its quality systems. 
  • Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Regulatory goals and objectives for the Regulatory team.
  • Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans.
  • Foster and maintain strong relationships with senior RAQA Regulatory leaders across the company and leverage best practices and opportunities to drive cross business collaborations and initiatives.
  • Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
  • Manages and develops team of Regulatory professionals

Job Requirements



Qualifications

REQUIREMENTS
  • Bachelor’s degree in a scientific discipline
  • 8 years in RA/QA role with 5 years in EPA regulated industry
  • 3 years of experience managing RA/QA associates
  • Ability to travel up to 25% of the time
PREFERRED SKILLS
  • Strong working knowledge of EPA Standards: Series 810 - Product Performance Test Guidelines, Series 830-Product Properties Test Guidelines, and Series 870 - Health Effects Test Guidelines
  • Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RA as well as across the broader organization.
  • Comprehensive knowledge and experience with EPA requirements such FIFRA, Pesticide Registration Manual, Health Canada Guidance Document for Disinfectant Drugs, and CFR 40 Parts 150 to 189  2009
  • Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process.
  • Attracts, develops, and retains high quality employees, foster employee engagement and professional development.
  • Experience in Medical Devices (HLD/Sterilants), Pharmaceuticals/OTC, Detergents, or liquid/lotion/cream.
  • Working knowledge of global medical device regulatory requirements and product registrations is preferred.
  • Experience with preparing and submitting materials for 510(k), MDEL and CE mark.
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.