Opis stanowiska
Are you a Regulatory Affairs Specialist looking for an exciting opportunity to make a significant impact? We are seeking a dedicated professional to ensure our operations comply with relevant regulations and industry standards, driving excellence in our products and services.
At DGS Diagnostics, we are committed to creating innovative solutions that improve lives. Our values drive everything we do, and with an international and open-minded approach, we foster a culture of trust, flexibility, social engagement, and personal development opportunities, while leveraging the latest technology to stay at the forefront of our industry.
Working with us, you will receive:
- A chance to develop yourself in a Polish-Danish culture based on openness and trust;
- The opportunity to exchange experiences and develop skills in an international environment;
- The option to relocate to Denmark if you are open to it. However, if you are looking for a job in the Szczecin area, we invite you to our office in Rosówek;
- Full introductory training;
- A full-time work agreement in an international, developing organization;
- Flexible working hours and a hybrid workplace;
- The possibility to improve your English on a daily basis;
- Close cooperation with your team and manager – Flemming Vinding.
Your key tasks will be:
- Ensuring regulatory classification and strategy is executed on selected product areas.
- Representing regulatory affairs in product development projects, and work close together with our regulatory compliance department.
- Creating and maintaining regulatory documentation.
- Ensuring alignment with the team handling product registrations.
- Providing regulatory assistance to Customer Service and other stakeholders.
- Collaborating with cross-functional teams to integrate regulatory requirements into business processes.
It would be great if you:
- Have experience in a similar position in an international company with responsibility for regulatory affairs within a related product area;
- Have proven knowledge and experience in ISO 13485 and MDR 2017/745;
- Have a positive mindset and enjoy working with others, as you will be collaborating with many different colleagues across the organization;
- Are diplomatic and able to coordinate the activities of the people around you;
- Ensure structure and are systematic, as these qualities come naturally to you.
Nice to have:
- Experience with UDI and labelling.
For questions regarding the recruitment process or our company, please contact our recruiter Kasia at kmas@dgs-daignostics.com.
Please send us your CV in English.