Manager Regulatory Affairs in Kloten, Switzerland at Nobel Biocare

Date Posted: 2/1/2018

Job Snapshot

Job Description

Job ID: NOB001938

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

The position is responsible for all RA deliverables in the management of projects related to product registrations and life cycle management for assigned international markets.


This position will be responsible for supporting international partners in obtaining regulatory approvals for new products (new developments) and implementation of changes (established products) in a timely manner. He/she will be responsible to conduct regulatory assessments regarding requirements and timelines for product approval and implementation of changes in relevant international markets, in close cooperation with the international partners and subject matter specialists in the organisation. He/she will support the international partners by providing necessary licences and certificates and act as a contact point to subject matter specialists within NB for specific registration relevant questions.


He/she will be involved in assessment, approval and release of communication material (IFU, leaflets, brochures) and development/improvement of RA related processes. Train and assist other departments to ensure continued compliance and timely market release.


  • Development of regulatory strategies for assigned projects
  • Support specific assigned international markets in product registration
  • Coordinate and monitor international submission projects for timelines and compliance
  • Assessment, approval and regulatory implementation of change requests in assigned markets
  • Review and approval of product related marketing material
  • Monitoring legislative environment in assigned markets
  • Training internally on relevant procedures and requirements
  • Highly organized and able to work under strict time lines
  • Excellent writing and communication skills

Job Requirements



Qualifications

  • Minimum 5 years experience in regulatory affairs within the Medical Device Industry
  • Experience with international Medical Device regulations and marketing requirements in international markets such as APAC and LATAM.
  • Experience with quality system requirements such as ISO 13485
  • Technical or scientific background
  • Experience in driving international registration projects
  • Knowledge of medical device legislation in EU and assigned international markets
  • Knowledge of relevant quality system requirements 
  • High intercultural competence
  • Highly organized and able to work under strict time lines
  • Excellent writing and communication skills
  • Proactive working attitude in an international matrix organisation


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.