Regulatory Affairs Specialist

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3Shape A/S is a Danish hi-tech company specializing in the production and development of 3D solutions (3D scanners and 3D software) for industrial and healthcare applications, such as hearing and dental aid production, where we have a global leading position.

Two graduate students founded 3Shape in the year 2000, and today the company's fast-growing team of 1600+ employees in 20 offices worldwide (Denmark, Germany, Poland, Ukraine, USA etc.) is serving customers in over 100 countries.

At 3Shape we are extremely proud of our market-leading and award-winning 3D scanners and medical device software solutions. And with our newly released corporate strategy, we focus even more on the development of the right solutions for our customers. And in order to ensure that such solutions become available globally at a fast pace, 3Shape establishes regulatory affairs unit in Kyiv.

In connection with establishment of regulatory affairs unit, we are looking for a Regulatory Affairs Specialist to work in our Kyiv office.

Responsibilities:

  • Conduction of regulatory activities linked to market expansion;
  • Close internal cooperation with especially RA colleagues and Development department;
  • Ensuring alignment of regulatory strategy to business strategy across functional areas;
  • Answering questions form health regulatory bodies and from the company affiliates and agencies concerning regulatory authority interactions;
  • Communication with customers regarding regulatory issues;
  • Providing the Development teams with regulatory input in order to produce timely regulatory packs for the projects as part of the product development process;
  • Involvment in various aspects of product development and international regulatory compliance. Furthermore, you will have to apply technical knowledge to review submitted documents and assess whether they are fit for purpose;
  • Managing transposition of international regulations into company product related requirements. Providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products including proofreading of labeling (IFU, labeling info);
  • Ensuring that the company's policies, procedures and operating guidelines conform to laws, regulations and industry practices. Developing & maintaining regulatory knowledge of regulations world-wide;
  • Understanding and handling questions related to the DHF’s;
  • Cooperation with the external consultants for obtaining and maintaining country specific product approvals;
  • Communication with Competent Authorities regarding vigilance cases, recalls and FSNs.

Your profile

  • Experience with regulatory affairs from a medical device company 
  • Strong planning, cooperation and communication skills.
  • Familiar with Medical Device Directive, FDA QSR, ISO 13485, ISO 62304, Low Voltage Directive and EMC Directive etc.
  • Fluent (or very good) English with excellent verbal and written communication skills
  • An interest for working in a multi-cultural environment with people who have various educational or work backgrounds.
  • Relevant theoretical background, preferably a university degree

We offer:

  • Participation in producing market-leading technology products for customers around the world
  • Work in a unique professional, friendly and supportive environment
  • Constant professional growth and development
  • Occasional business trips to Western Europe
  • Competitive salary level
  • Good working conditions in a comfortable office (not open space!) near National Technical University “KPI”
  • 39 working hours per week within flexible time-frame from 8:00 till 20:00
  • Possibility of partially remote work
  • A parking lot with free spaces for employees
  • A healthy work-life balance
  • Annual paid vacation (24 working days)
  • Paid sick leaves and a child sick leaves
  • Maternity and paternity leaves
  • Medical insurance (incl. massage in the office).
  • Compensation of lunches
  • Regular company events
  • Opportunity to become a part of the success that 3Shape has created over the past 20 years  

We will be glad to welcome you in our team!

For more information, visit our web-site: www.3shape.com.

You can follow us on social media:

https://www.facebook.com/Lifeat3shape/

https://www.linkedin.com/company/3shape/

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

UA - Kyiv

Polova St, 21
02000 Kyiv Directions View page

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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