Are you looking for a role where precision and knowledge directly impact the success of global products?
Join the team in a key operational support role, expertly handling Regulatory Affairs analysis.
what we offer- efficient recruitment process
- 100% remote working model
- flexible working hours
- private medical care
- life/accident insurance (PZU)
- sports card (for you or your loved ones)
- online cafeteria – benefit platform
- temporary employment contract - min. 12 months
- coordinate medical device and cosmetic regulatory affairs for US and OUS
- coordinate communication internal and external to the regulatory function
- implement regulatory strategies
- support new product introductions and existing product changes
- partner to determine global regulatory strategy
- participate in minimum change documentation
- support risk management files and completion
- support UDI
- review and approve product labelling
- min. Bachelor’s degree
- 1-5 years of regulatory affairs experience in a private, public, government or military environment
- ability to read, write, and speak English fluently
nice to have:
- certified Regulatory Affairs professional (RAC)
- advanced degree in scientific discipline
- experience with regulatory strategy
- experience with electronic systems (e.g., SAP, data acquisition systems, regulatory databases, UDI systems)
- strong communication and collaboration skills
- ability to work hours to match St Paul, MN, USA time zone
Agencja zatrudnienia – nr wpisu 47
ta oferta pracy przeznaczona jest dla osób powyżej 18 roku życia
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