Job Opportunities in Malaysia


September 10, 2024

SCIKEY (SRKay Consulting Group)

Manjung

FULL TIME


Regulatory Affairs Executive (Manufacturing)

Key Job Responsibilities:
  • 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.
Job Requirements
  • 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
Job Type: Full-time
Pay: RM3,500.00 - RM5,000.00 per month
Schedule:
  • Monday to Friday

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