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1 listing(s) available.
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29 Apr 2024
RA Specialist
Malaysia
Permanent PositionOur client leads the world in medical tech, focusing on advanced solutions for critical care and emergencies. Their innovative devices like defibrillators, ventilators, and monitors are used worldwide by medical pros, aiming to improve patient outcomes.Job Description
- Establishes partnerships for timely product approvals in APAC regions.
- Represents regulatory affairs in project teams.
- Provides regulatory guidance to cross-functional groups.
- Develops APAC regulatory strategies and communicates with authorities.
- Coordinates regulatory filings and certifications, stays updated on regulations, and participates in audits.
Expires on 29 Jun 2024Posted By
Yap Man Ni ( https://about.peoplefirst.jobs/manni.yap)Tel: +6011 1157 1963
manni.yap@peoplefirst.jobsRequirements
- Multilingual proficiency in Malay, Mandarin, and English, facilitating effective communication in diverse settings.
- Extensive experience in regulatory affairs, particularly in CFDA submission processes and filings across APAC regions like Taiwan, Malaysia, and Singapore, demonstrating strong analytical skills and attention to detail.
- Proven ability to work independently and within teams, adapt to changing environments, prioritize tasks effectively, and meet regulatory reporting deadlines, supported by solid understanding of APAC regulations and medical device industry standards.