Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we have our Business Centre that works with global financial operations, orders administration, HR and IT support, Legal & Business Ethics, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here!
About the department
The job is located in Coloplast Business Centre in Szczecin, Poland. The team will be involved in the development of regulatory strategies and registration of medical devices in various countries around the world. You will participate in writing and reviewing of documentation and will be responsible for ensuring that the technical file supporting our products is in compliance with relevant regulatory requirements. As we constantly strive to improve existing procedures, systems and processes in Coloplast, our team will also be expected to participate in cross-functional working groups building knowledge across the entire organization.
- Coordinate and compile regulatory files to ensure marked expansion and re-registrations within the allocated registration projects for medical devices
- Maintain registrations in defined areas to ensure regulatory compliance
- Surveillance of legislation and regulations for medical devices in defined areas
- Participate in optimising of registration processes
- Communicate regulatory requirements and regulations for medical devices effectively in RA HQ within defined areas
- Data entry within the registration tool, to continuously reflect a full overview of global product registrations
- Contribute to regulatory compliance for Coloplast product portfolio and business areas
- Degree within a scientific field
- Min 1-year experience with regulatory activities within medical devices and/or other regulatory environment
- Knowledge of directives, standards and guidelines within the regulatory medical device area and/or other related regulatory areas (e.g. MDD, MDR, ISO 13495)
- Knowledge of design control and regulatory approvals from a documentation perspective
- Strong communication skills
- Fluent in both verbal and written English
- IT skills and knowledge in Excel
- Quality mindset
- Fixed term contract (min 12 months) with the possibility of extension
- Hybrid and onsite work from our office in Szczecin / Remote work possibilities (from Poland)
- Flexible working hours, Mon-Fri
- International work environment with Scandinavian culture
- Opportunity to use and develop foreign languages in daily work
- Fantastic work atmosphere full of respect and partnership
- Internal trainings available in CPBC Academy
- Modern workplace
- No dress code zone
- Great company events
- Sports card
- Private medical care
- Transportation co-funding
- Restaurant card
- Holiday bonus and occasional cards
- Delicious coffee and fresh fruits
Poznaj
Coloplast Business Centre Sp z o.o.
Coloplast opracowuje produkty i dostarcza usługi ułatwiające życie osobom z dolegliwościami o bardzo osobistym charakterze. W Coloplast Business Centre świadczymy wsparcie z zakresu księgowości, IT, administracji zamówień, dokumentacji medycznej czy marketingu. Szukamy synergii pomiędzy tymi funkcjami dla tworzenia udoskonaleń i nowych możliwości.Wspierając codzienną pracę Coloplast na całym świecie, czynimy łatwiejszym życie naszych pacjentów.