Head of Regulatory Affairs Implant Systems in Kloten, Switzerland at Nobel Biocare

Date Posted: 1/25/2018

Job Snapshot

Job Description

Job ID: NOB001581

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.



Description

  • Lead the RA team supporting product development within Implant System divisions to ensure RA strategy alignment with global strategic initiatives and on time execution.  Principal responsibilities include but are not limited to:
  • Lead, mentor and development of the RA team supporting development projects within the BU Implant Systems to ensure regulatory approval in initial markets (EU, AUS, NZ, US and CAN). Develop and execute RA strategies in line with launch activities and company strategies for those major markets.
  • Ensuring policies and standards are understood and followed.
  • Ensuring alignment and proper communication and training of RA relevant processes and provide guidance to the RA and other teams. 
  • Monitor project progress and provide reporting on a regular basis to senior management to ensure timely execution of RA strategies to support launch activities.
  • Lead and support external and internal audits and inspections, support global regulatory compliance activities
  • Monitor closely and provide guidance and awareness of guidelines, regulations, changes in the marketplace and other information relating to global regulatory compliance for the assigned markets.
  • Be an expert in regulatory new product development related activities within the organization.
  • Develop relevant metrics to track RA and other cross-functional partner activities in NPD Implant Systems 
  • Maintain and develop relevant SOPs and work instructions
  • Train internal/external stakeholders on RA relevant processes
  • Prepare and monitors budgets for the group as appropriate.

Job Requirements



Qualifications

  • Technical or scientific background, university degree is an advantage
  • Excellent knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
  • Excellent knowledge of product development processes in MD industry
  • Excellent knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
  • Fluent in English, German or further languages are an advantage
  • Highly organized and able to work under strict time lines
  • Strong interpersonal skills and proactive working attitude in a international matrix organization
  • Excellent writing and communication skill
  • Experience in preparation for notified body audits and FDA inspections
  • Experience in managing cross functional projects and teams
  • Experience in leading and managing people
  • Minimum 5 years experience in regulatory affairs within the Medical Device Industry
  • Experience with EU, US, AUS and CAN medical Device regulations
  • Experience with software development requirements (IEC 62304 ), usability (IEC 62366) as well as electro-mechanical product standards such as IEC 60601 a plus


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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 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.