Ra Specialist

2 weeks ago


Malaysia PeopleSearch Full time

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 2024 _

Posted By

Tel: +6011 1157 1963**Requirements**:

- 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.