Regulatory Affairs Specialist, Shanghai

3Shape company is looking for the Regulatory Affairs Specialist for Shanghai Office.
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Reporting line: RA Lead in China Office

Work location: Shanghai Office

Responsibility:

  • Proactively partner with Regulatory Affairs DK, R&D, Program leader, quality, clinical and marketing for optimal clinical/regulatory pathway. To confirm the product’s compliance is within NMPA regulatory requirement.
  • Lead to develop registration scope and registration plan with project team. Update the registration status to project team timely. Ensure the deliverables of regulatory affairs could meet the project schedule.
  • Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for timely submission to Regulatory authorities, and close follow up until approval.
  • Monitor and track the trends of latest regulatory requirements changes/updates. Assess the impact of the changes and propose proper adjustment to the compliance of changes in collaboration with the project team and/or regulatory consultants, if relevant.
  • Review product and packaging labels, IFUs, marketing material
  • Responsible for communication with competent authorities and develop an external engagement network across NMPA, Provincial FDA’s and official test house is desired.

 

Requirements:

  • Capable to work independently, within minimal direction, assists in fulfilling Regulatory compliance requirements by thorough understanding/evaluation of Regulatory standards for software medical devices and execution with action to implementation.
  • Education: Relevant technical, engineering, or natural science background, preferably a university degree
  • Minimum 3 years of experience with regulatory affairs from a medical device company, preferably with software devices
  • Familiar with country specific Medical Device regulation (NMPA, CE) as well as ISO13485, ISO 62304, ISO 14971, cybersecurity. Knowledge of Low Voltage Directive and EMC Directive ietc.
  • Excellent planning, cooperation, and communication skills
  • Fluent in English with excellent verbal and written communication skills
  • Comfortable to work in multi-culture context.

 

 We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,600+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook.

Or, know someone who would be a perfect fit? Let them know!

CH - Shanghai

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Our biggest assets are our people and culture 💗

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. Experience the everyday #lifeat3Shape across the globe on Facebook. 

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