Coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
Provides advice to internal and external teams in interpreting relevant guidance documents and standards.
Contact local authorities and organizations for both regulatory problems solving and obtain updated information on current and developing regulations.
Review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
Provide training when necessary and assist with the development of the respective countries\' Regulatory Affairs infrastructure to facilitate greater speed to market.
Take charge of QA (complaint reporting etc) for all subsidiaries
Requirements:
Degree in Biomedical engineering, Sciences
Minimum 1 Year of relevant working experience
Interested candidates please send a copy of your resume to lynnho
Healthcare / Pharmaceutical / Life Science / Medical Device Others Public Sector / Government & Statutory Boards Semiconductor / Electronics / Engineering
Specialization
Engineering Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs Professional Services
Location
Central, North, East, West
Employment Type
Contract / Temp Permanent
Salary
S$2,601 - S$4,000 / mth
If you meet the requirements of this role, please email a detailed resume in Word document to Lynn Ho Lin Ying. CEI Registration No.: R23114223 Email: lynnho@recruitexpress.com.sg
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.