Growing startup Medical Device/IVD company \xe2\x80\xa2 Require people experienced in liaising with FDA/EU.
Regulatory Affairs Specialist (Global)
Our client is a growing IVD company with an existing global presence.
Responsibilities:
Liaise with various global regulatory authorities including FDA, EU and others for product registration.
Maintains approvals/licenses/authorizations for existing marketing authorization.
Prepare and submit regulatory filings, such as 510(k) submissions, premarket approval applications, and annual reports, in accordance with regulatory requirements and timelines
Work closely with cross-functional teams such as R&D, Clinical Affairs, commercial team etc.
Requirements:
At least 3 years of experience in regulatory affairs, liaising with FDA/EU.
Familiar with IVD products or medical devices.
Ability to communicate with internal and external stakeholders.
To Apply: Kindly send your CV to Wei Ting Foong at weiting.foong@springasia.com.