Kto szuka:
Coloplast Business Centre Sp z o.o.
Stanowisko:
Regulatory Affairs Specialist
Lokalizacja:
Szczecin
zachodniopomorskie
Opis stanowiska podany przez pracodawcę:
The job:
You will support the Regulatory Affairs Department in Denmark:- 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
Wymagania stawiane pracownikowi:
Qualifications:
We are looking for an experienced Regulatory Affair Specialists with documented skills. Our ideal candidate for the job has: - 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
Firma oferuje:
We offer:
- 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
That's not all! We have even more for you:
- 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
Kontakt do pracodawcy:
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