Ho Wah Genting Bhd is looking for new potential candidates to fill in for Regulatory Affairs Executive position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
• To ensure regulatory compliance of Company products and review documentation pertaining to medical device standards of (MDA), NPRA, Suruhanjaya Tenaga, SIRIM.
• According to the Company’s plan carry on for product registration, system certification, renewal of the certification obtained, application for replacement of certificate.
• Follow up the registration and internal review of registration application information throughout the process and submit the application information to complete the registration application and supplementary application related work.
• Follow up the product registration progress, communicate with the government and relevant industry departments on registration matters, coordinate and deal with problems in the registration process, and ensure that registration approval documents are obtained on time.
• Liaise with manufacturer on dossier compilation for submission to MDA, NPRA.
• To keep abreast of the updates on local medical device and pharmaceutical products laws, regulations, standards, and guidelines.
• To maintain and update regulatory files/database for internal record keeping.
• Implement GDPMD setup in Company and liaise with external consultant for GDPMD Quality Management System.
• Prepare application for Establishment Licence with MDA
• Liaise with Conformity Assessment Body (CAB) for GDPMD, product registration and yearly surveillance audit.
• Bachelor’s Degree in Pharmacy / Pharmacology, Medicine, Bio-Medical, Biotechnology, Chemistry, Biology or equivalent.
• At least 3 year working experience in product submission and registration of schedule poison, OTC, health supplement or traditional medicine with NPRA.
• Experience in vaksin and biological registration.
• Candidate with QA/QC and manufacturing background will be an added advantage.
• Positive working attitudes, teamwork spirit, have sense of urgency, self-initiative, self-discipline and have eyes-in detail.
HWGB’s principal activities are investment holding company and the provision of management services, manufacturing and trading of wires and cables, moulded power supply cord sets and cable assemblies for electrical and electronic devices and equipment. It is also involved in travel agent and travel retail outlet as well as provision of consultancy services to foreigners to reside in Malaysia.
New Business Activities
- Distributions of biotechnology products, tools and related technologies and software
- Engaged in business of trading and sales of nutraceutical products, dietary supplements and functional food
- Engaged in business of health and wellness program activities and trading in health and beauty products.
How To Apply
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