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Manager, Global Regulatory Intelligence in Brea, California at Danaher

Date Posted: 4/13/2019

Job Snapshot

Job Description

Job ID: DEN000366

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

JOB SUMMARY:  The  Manager, Global Regulatory Intelligence is responsible for monitoring the regulatory landscape to identify & understand emerging changes in law, regulations & guidance that may impact DHR Dental Platform global medical device development programs & regulatory strategies. This role will provide analysis of new regulatory guidance, laws and competitive dynamics, business impact and help drive a consistent Dental Platform (DP) position globally.
 
ESSENTIAL DUTIES & RESPONSIBILITIES:
  • Monitor and assess the US, EU and global regulatory environment to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations and laws that may have an impact on Dental Platform products and regulatory business processes.
  • Partner and collaborate with regulatory affairs leadership and cross functional business partners to translate draft legislation, regulations and guidelines into influencing strategies aligned with DP’s regulatory and business priorities.
  • Identify and align region teams on potential implications of emerging regulatory requirements and participate in development of technical comments on proposed regulations and/or guidance documents and other external requests for industry input by regulatory bodies.
  • Effectively communicate regulatory intelligence and strategy to regulatory leadership and internal stakeholders.
  • Develop and lead relationships with external (trade associations, etc) and internal stakeholders to advocate DP’s regulatory policy agenda.
  • Proactively support industry engagement strategies to influence evolving medical device regulation and minimize regulatory burden.
  • Support training and development for Central and Regional Regulatory teams in effective external engagement.
  • Develop standard work (including IT solutions for central data repository) and share best practices.

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelor's degree (B.A. or B.S.) in a science discipline from a four-year college or university.
  • Possess 5+ years of experience in medical device regulatory affairs covering regions such as US, EU, Asia Pacific, LatAm, etc.
  • Ability to travel 50-60% domestically & globally.
PREFERRED SKILLS/EXPERIENCE:
  • Ability to work independently in fast-paced environment with little supervision.
  • Ability to adapt to constant change and influence positive change effectively.

  • Team-oriented and responsive to customer needs.

  • Attention to detail and results-oriented.


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.