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Regulatory Manager Männedorf Switzerland,  

TECAN (company)


Posted on : 21 August 2017

Project Description

Join Tecan! Join the market leader! Work in an international and dynamic environment, share our success!

Tecan is a leading company in the fast growing global life science supply industry. We are specialized in the development, production and distribution of automation solutions for laboratories in the market segments life sciences, clinical diagnostics and forensics.

Founded in Switzerland in 1980, the company has manufacturing, research and development sites in Europe and North America and maintains a global sales and service network in 52 countries.

You will have the unique opportunity to make an active contribution to the successful further development of our products. To complete our Quality & Regulatory organization we are seeking for a

Regulatory Manager

who ensures that all global regulatory compliance programs & initiatives are maintained and advanced according to Tecan processes, to our highest quality & regulatory standards.
  
Furthermore you be responsible for surveillance of regulatory policies and contributing to advancement of global strategic regulatory affairs initiatives through knowledge sharing, development of new procedures and processes, and training. You will define applicable regulations for products and develop regulatory strategies for commercialization of Tecan products and services worldwide. You will serve on project teams internally representing regulatory affairs department. Additionally managing vigilance reporting and post market surveillance as well as reviewing marketing material is also part of this exciting role.
 
Requirements:

For this position we are looking for person with a a degree in microbiology, chemistry, , medical or other scientific discipline or equivalent experience and who has several years
RA experience , who is looking to develop their career within the Quality and Regulatory function. 

You have a proven track record working in a GMP environment, in IVDD and applying regulations to a variety of medical device product lines ( 3-5 years + of experience). Experience working with IVD / clinical diagnostics products including reagents are desired.
  
With your excellent social skills you have the ability to communicate at all management levels and have a customer-oriented mindset. You can demonstrate that you have made improvements to practices/procedures and work quickly and accurately.
You are a highly organised person who is able to set priorities and will persevere to make sure tasks are completed on time. Good German and very good English skills are essential for this role located in M

Locations

8708 Männedorf, Switzerland

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