Regulatory Affairs Specialist (global)
Singapore, Singapore
Job Description
- Growing startup Medical Device/IVD company \xe2\x80\xa2 Require people experienced in liaising with FDA/EU.
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.
- 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.
Kindly send your CV to Wei Ting Foong at weiting.foong@springasia.com.
EA License No. 09C5803
Registration No. R2196804
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Job Detail
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Job IdJD1320363
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned