Are you looking for the next challenge in your career?
Would you like to be part of an exciting highly qualified team of professionals in an international environment
?We are currently looking for a qualified Regulatory Affairs Specialist
.Join an international division and work alongside with some of the most talented engineers and technicians from all over the world
.
Your benefi
ts: Competitive Sal
ary.Long-term secure contr
act.International Project with top technolo
giesPossibility of working remotely with a flexible sched
ule.Integration in a highly qualified team of profession
als.Travel abroad with your proj
ect.Specialized training and continuous professional developm
ent.Social benefits and flexible compensation p
lan.
Responsibil
ities: Support and manage regulatory activities related to the registration and approval of medical devices in
China.Navigate and coordinate NMPA submission and approval pro
cesses.Ensure compliance with Chinese regulatory requirements and applicable sta
ndards.Collaborate with cross-functional international teams, including Quality, Clinical, and Product Devel
opment.Provide regulatory guidance and risk assessment throughout the project li
fecycle
R
equirements Proven experience in Regulatory Affairs within the medical devi
ce industry.Hands-on experience with NMPA regulations, submissions, and approva
l processes.Strong understanding of the Chinese regulator
y landscape.Experience with Class II and/or Class III medical devices is highl
y preferred.Exposure to CGM, diabetes care, diagnostics, digital health, or wearable medical devices is a stron
g advantage.Fluent Engli
sh required.Chinese language skills are a
strong plus.German is considered a
nice-to-have
We positively value all work or study exper
ience abroad.All positions require a high level of English (at least B2) - please send your detailed C
V in English.