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Vice President QA/RA in Kloten, Switzerland at Nobel Biocare

Date Posted: 5/11/2019

Job Snapshot

Job Description

Job ID: NOB002926

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


The Vice President of QA/RA will direct activities of the Quality Assurance and Regulatory Affairs organization to include systems, policies and procedures required to ensure that all products fulfill all legal requirements and conform to the established standards of quality and uniformity across the company’s manufacturing sites. The products are predominantly Class IIB devices but the increased importance of digitization and integrated software workflows will need to be dealt with.
Org Structure: there are currently 3 direct reports: Head of RA, Head of QA and Head of Compliance. Total team covers 217 employees.

Change management is a key part of the role, especially initially as the new incumbent will continue to chart the course to achieve strategic priorities of Nobel Biocare Systems.

  • Development and implementation of a strong and effective RA/QA strategy for Nobel Biocare Systems globally
  • Optimization of both areas of responsibilities regarding the fulfillment of regulatory requirements as well as the requirements as a result of the business strategy
  • Ensure global planning and implementation of the quality and regulatory strategy and standards for all processes and products which are sold by Nobel Biocare Systems
  • Manage how to deal with digital workflow from the regulatory point of view
  • Develop and implement the Quality Vision and related strategies and policies required by the quality organization to support these
  • Optimization and alignment of various RA/QA systems where necessary
  • Ensuring appropriate approvals of for Nobel Biocare Systems products worldwide
  • Ensuring global compliance of all processes and products, related to legal and regulatory requirements together with an understanding of the business approach
  • Manage communication and negotiations with Competent Authorities or Notified Bodies
  • Lead RA / QA team globally
  • Identify training needs and deliver the respective trainings as needed
  • Liase and collaborate with teams in other dental companies

Job Requirements


  • MS or PhD in a natural science discipline and/or in mechanical engineering.
  • Knowledge of the applicable regulation such as ISO 13485, 21 CFR820, JPAL. Knowledge of production processes preferably in the production of implants and prosthetic components of various materials, CAD/CAM related processes and Software Development.
  • Critical Skills/technical know-how: (what the role holder must be able to do)
  • Proven management leadership skills and ability to build global structures. Proven ability in working in complex, cross-functional and multi-cultural structures.
  • Strong people management skills. Must be accessible and integrative with strong communication capabilities.
  • Hands-on approach, solution-oriented combined with a strategic mindset and driving results. Project Management and team building capability
  • Fluent written and spoken English

  • Vast experience in a leadership position in Quality Management and Regulatory Affairs in the medical device industry.
  • FDA experience is a must

Success Factors:
  • Strategic orientation and global alignment of the Quality Management and global regulatory strategy.
  • Achieving and maintaining a compliant state of the Quality Management system.
  • Making pragmatic decisions in accordance with the regulations.
  • Define understandable key metrics to show the status of the Quality Management System.
  • Initiate and drive quality improvements throughout the organization.
  • Identify relevant Quality training needs and deliver the respective trainings. 
  • Keep a high awareness for Quality within the company.


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.