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Regulatory Affairs Manager

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About us

3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics. Creating great innovation requires diverse teams. Our growing talent pool of over 1,500 employees spans 30+ nationalities and is energized by knowing that together, we contribute to a better world. 3Shapers are entrepreneurs, challengers and innovators… values that are at the heart of everything we do.


About the role

   


Your key responsibilities will be to:

  • Provide the Regulatory Affairs department with country specific regulatory input supporting product development and product lifecycle management
  • Ensure regulatory approval and maintenance of products (active devices and software as a medical device) and in collaboration with regulatory consultants, if relevant
  • Review product and packaging labels, IFUs, marketing material
  • Answer questions from Competent Authorities concerning regulatory topics in collaboration with Regulatory Affairs department  and/or regulatory consultants, if relevant.
  • Responsible for communication with Competent Authorities with regard to vigilance cases, recalls and FSNs in collaboration Regulatory Affairs department and/or regulatory consultant, if relevant
  • Communication with customers regarding regulatory issues
  • Ensure that the company's policies, procedures and operating guidelines conform to country specific laws, regulations and industry practices.
  • Responsible for the daily collaboration with regulatory consultants as well as evaluation of performance and costs.
  • If decided, establish and maintain procedures required for local 3Shape entity to act as Marketing Authroisation holder
  • Act as qualified person for local 3Shape office, if required by Competent Authority
  • Act as QMS Management Representative, if required by Competent Authority
  • Act as local responsible person for post-market surveillance activities, if required by Competent Authority

  


To succeed in this position, you will need to:

  • Education: Relevant technical, engineering or natural science  background, preferably a university degree
  • Experience with regulatory affairs from a medical device company, preferably with active devices and/or software devices
  • Familiar with country specific Medical Device regulation (PMDA, KFDA, ANVISA, CFDA) as well as ISO13485, ISO 62304, Low Voltage Directive and EMC Directive etc.
  • Excellent planning, cooperation, and communication skills
  • Fluent in English with excellent verbal and written communication skills

 


What do we offer  

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Shanghai

69 Dongfang Rd
200070 Pudong Xinqu Directions

Inside 3Shape

Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way.

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