Job Opportunities in Malaysia
September 10, 2024
SCIKEY (SRKay Consulting Group)
Manjung
FULL TIME
Regulatory Affairs Executive (Manufacturing)
Key Job Responsibilities:
Pay: RM3,500.00 - RM5,000.00 per month
Schedule:
- Ensure that the company’s products comply with country regulations.
- Be responsible for sending gloves for testing and following up, including filling out the necessary documents and coordinating the testing of products with external labs.
- Assist the superior in preparing Purchase Requisitions (PR) for glove testing and ensure that payments are made accordingly.
- Provide feedback to Sales & Marketing and Customer Care personnel regarding information pertaining to testing.
- Update external documents on new revisions such as standards, regulations, and guidance.
- Update training materials and procedures according to updated standards and regulations for relevant countries.
- Update the product portfolio every six months.
- Ensure that quality standards are met, and submissions meet strict deadlines.
- Update and maintain FMEA, Risk Management Files, Post Market Surveillance, and Clinical Evaluation.
- Be subject to transfer to other departments at the discretion of the company.
- Ensure that RA areas and storage areas are in audit-ready status at all times and that GDP and c GMP are followed.
- Ensure that all activities related to work do not impact the environment and comply with Good Environmental Practices (GEP).
- Ensure compliance with all relevant legislation, such as OSHA, FMA, EQA, etc.
- Perform any other assignments as assigned from time to time.
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Regulatory Affairs) is preferred.
- Preferably 2-5 years of experience in Regulatory Affairs, Quality Assurance, or a Testing Laboratory environment.
- Familiarity with regulatory standards and requirements applicable to medical devices or consumer products.
- Strong organizational skills and attention to detail.
- Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams
Pay: RM3,500.00 - RM5,000.00 per month
Schedule:
- Monday to Friday
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