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Do you want to make a significant difference in how the world is looking tomorrow and contribute to the innovation of state-of-the-art, cutting-edge technology products?
Then look no further and join our Regulatory Affairs Team at Männedorf, Zürich as


Senior Regulatory Affairs Specialist 80-100%

 

What you will do 
In this challenging and important role, you ensure and enforce global regulatory compliance programs to maintain and advance regulatory compliance in area of responsibility (e.g. ISO 13485, IVDR (EU) 2017/746, 21 CFR Part 820, etc.).

 

Responsibilities will include 

  • Give regulatory advice consistent with Tecan global regulatory affairs policies
  • Defines product classifications for defined markets for area of responsibility
  • Supports surveillance of regulatory policies and contributing to advancement of global strategic regulatory affairs initiatives
  • Reviews technical change requests and determines impact to current regulatory status for Tecan’s products
  • Prepares regulatory strategies and assessments for internal project teams

 

What you bring along 

  • A degree in scientific discipline
  • RAC certification would be beneficial
  • Experience in the medical device or IVD industry
  • Minimum 3 years of experience in regulatory affairs
  • Knowledge with FDA Medical Device Regulations
  • Good technical writing skills
  • Fluent English skills, German is a plus

 

What you will get

  • Comprehensive Compensation and Benefits package
  • Progressive employment conditions
  • Exciting career opportunities
  • Wide range of training courses 
  • International and diverse environment (30+ different nationalities) 
  • Strong company culture with rich history 
  • Global mindset with “Swissness” at heart
  • Extremely attractive location overlooking the lake of Zurich 

 

Look no further and apply now!
We are looking forward to receiving your application online. Please submit your resume (w/o picture and w/o cover letter, reference letters and diplomas are optional).

We will only consider applications that fully meet our requirements.

 

#lifescience #healthcare #automation #medicaldevice #biology #biotechnology #IVDR #RoHS #eMDR #PMA #designcontrol 

We care about people - Join the market leader.
People every day all around the world will benefit from more personalized healthcare. The promise of better, faster, more cost efficient solutions is now within our grasp. And that’s the world in which Tecan plays a vital role – helping advance healthcare – through advanced life science research and diagnostic solutions. We constantly seek new ways to steer innovation.

Every lab. Every day. Empowered.
Our vision is to empower every laboratory, every day, around the world with Tecan technology, products and support. We will help to shape the future of automated workflows in life sciences and clinical diagnostics through unrivaled expertise, products and customer support.

We care about our culture.
Our values – trust, highest standards and ambition – are the cornerstones of our business, and give us the framework for the Tecan culture. We foster a positive and empowering environment, which allows us to bring our passion and energy to work. This helps us to deliver on our customer promise – ‘Always there for you’.

Legal entity:  Tecan Schweiz AG
City:  Männedorf
Country:  CH