Medical Device Regulatory Affairs Specialist

Medical Device Regulatory Affairs Specialist

Qualtek Consulting Sdn. Bhd. is currently looking for a Medical Device Regulatory Affairs Specialist. The candidate will be mainly responsible for handling and supporting the immediate supervisor in executing product registration activities. He shall also assist in catering to the in-country representation needs of clients.

Key Responsibilities:

• Ensures effective presentation of technical dossier to regulatory agencies.
• Manages product certificates and performs other tasks related to in-country representation of principals.
• Ensures our activities accord with GDPMD.
• Develops & maintains updated knowledge of applicable international/regional and local regulations and guidelines.
• Performs other duties and responsibilities as may be assigned from time to time.

Job Requirements:

• Bachelor’s degree in Science/ Pharmacy/ Bioengineering/ Biotech/ Biochemical/ Electrical Engineering or related field from a reputable university.
• Minimum 1 year of regulatory experience, preferably in the pharmaceutical or medical device industry.
• Proficient in English and good in Bahasa Malaysia.

Benefits:

• Salary: Negotiable.
• EPF, EIS, SOCSO included.
• Dress Code: Business Casual.
• Benefits: Medical, Bonus, Miscellaneous allowance.
• Working Hours: Mondays-Fridays 9am – 6pm.
• Location: 3 mins walk to LRT station.