Regulatory Affairs Specialist
3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively. Our products are market leading innovative solutions that make a real difference in the lives of both patients and dental professionals around the world.
3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine, North Macedonia and with a production site in Poland.
We are a global company with presence in Europe, Asia and the Americas. Founded in a year 2000, today, we serve customers in over 100 countries. Our growing talent pool of over 2000 employees spans 35+ nationalities .
3Shape as an employer is committed to Ukraine . Our UA office has a 16 year-old history, and we are continuing to grow, hire and take care of our employees even during the war in Ukraine. Among other actions, we support our employees who are called to the military service, as well as care about our employees’ mental health by implementing different supportive activities.
If you are looking for stability and confidence in your future, we are the right place for you.
About the role
We aim to provide a regulatory presence worldwide and hence are looking for Regulatory Affairs Specialist to join our team in Kyiv.
As Regulatory Affairs Specialist you will drive obtaining and maintaining regulatory approvals for 3Shape 3D scanners and software medical devices as well as providing global registration support for the organization.
- Conduction of regulatory activities linked to market expansion and maintenance.
- Cooperation with external consultants for obtaining and maintaining country specific product approvals.
- Close internal cooperation with especially RA colleagues and Development department.
- Ensure alignment of regulatory strategy to business strategy across functional areas.
- Answering questions from health regulatory bodies and from the company affiliates and agencies concerning regulatory authority interactions.
- Communication with stakeholders regarding regulatory issues.
- Involvement in various aspects of product development and international regulatory compliance. Furthermore, you will have to apply technical knowledge to review submitted documents and assessing whether they fit for purpose.
- Manage transposition of international regulations into company product related requirements. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products including proofreading of labeling (IFU, labeling info);
- Ensure that the company's policies, procedures and operating guidelines conform to laws, regulations and industry practices. Develop & maintain regulatory knowledge of regulations worldwide.
- Capable for understanding and handling questions related to the DHF’s.
- Participate in communication with Competent Authorities with regard to vigilance cases, recalls and FSNs.
- Experience with regulatory affairs from 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 in working in a multi-cultural environment with people who have various educational or work backgrounds.
- Relevant theoretical background, preferably a university degree.
- Passionate about new technology and knowledge.
Being the part of us means:
- Meaningful work that helps to change the future of dentistry
- Work in a unique professional, friendly and supportive environment
- Constant professional growth and development
- A healthy work-life balance
- Possibility of flexible remote work
- Comprehensive benefits incl. 24 working days of annual vacation; medical insurance; compensation of lunches; paid sick leaves and child sick leaves; maternity and paternity leaves etc
- Good working conditions in a comfortable office (not open space!) near National Technical University “KPI”
- A parking lot with free spaces for employees
- Occasional business trips to Western Europe
- Opportunity to become a part of the success that 3Shape has created over the past 22 years.
Want to join us and change the future of dentistry?
For more information, watch our corporate video youtu.be/38-_SfPBptw, visit our web-site: www.3shape.com or contact by email firstname.lastname@example.org.
Information about our open vacancies you can find here: www.3shape.com/...porate/Careers/#vacancies
You can follow us on social media :
- Regulatory Affairs
- UA - Kyiv
- Remote status
- Hybrid Remote
UA - Kyiv
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 LinkedIn.
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.
Our growing talent pool of over 2,000 employees spans 50+ nationalities and is energized by knowing that together, we contribute to a better world.
Two graduate students founded 3Shape in Denmark’s capital, Copenhagen in the year 2000. Today, 3Shape employees serve customers in over 100 countries. As a privately-owned company, decisions are made fast, and we remain agile.
3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine and Macedonia with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.
Regulatory Affairs Specialist
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