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Regulatory Affairs Manager - US in Kloten, Switzerland at Nobel Biocare

Date Posted: 12/1/2018

Job Snapshot

Job Description

Job ID: NOB002699

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

In this function the position is responsible for all RA deliverables linked to the management of new product development activities with focus on Implant systems.

The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US. This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation. He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.

The RA manager will support international product registration by consulting the responsible RA manager for international projects.

Monitoring of legislative environment in main markets, i.e. EU, US and define and maintain an overview of the regulatory requirements and changes in the areas if applicable.

Assessing, approval and release of communication material (IFU, leaflets, brochures). Train and assist other departments to ensure continued compliance and timely market release.

Main Responsibilities:

  • Development and execution of regulatory strategies for assigned development projects on implant systems
  • Support of product development in cross functional teams
  • Creation, review and/or approval of documents of the design control process
  • Accountable for regulatory compliance
  • Support international product registration
  • Assessment, approval and regulatory implementation of change requests
  • Review and approval of product related labeling and marketing material
  • Support SAP based reporting systems
  • Monitoring legislative environment in relevant markets
  • Training internally on relevant procedures and requirements

Job Requirements



Qualifications

  • Experience in regulatory affairs (preferably within the Medical Device Industry)
  • Good Knowledge of RA legislation EU ,US and corresponding guidelines
  • Good knowledge of product development processes.
  • Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
  • Fluent in English, 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 skills
  • Experience in preparation for notified body audits and FDA inspections
  • Experience in managing cross functional projects and teams
  • Technical or scientific background, university degree is an advantage


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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.

To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland.

 

For agencies: please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group