EXECUTIVE REGULATORY AFFAIR

Requirements:

• Bachelor's degree in Quality Management or a related field
• Minimum 2 years of experience in regulatory affairs, preferably in the medical device.
• Strong attention to detail and ability to work under pressure to meet tight deadlines.
• Excellent communication, organizational and project management skills.
• Proficiency in regulatory submission.

Job Descriptions:

• Conduct internal audit and drive continuous improvement efforts.
• Conduct follow up audit/checks to monitor non-conformities and ensure other actions are complete.
• Recommending appropriate changes as a result of the audit result to Foresight’s Quality Management Systems.
• Develop, register, facilitate and maintain all regulatory submission related to establishment and product registration with applicable Regulatory Authority.
• Monitoring of licensing and certification activities such as MIDA, GDPMD, ISO 13485, CFS, and export.
• Liaising with Regulatory Authority, Designated agents, and notified bodies on all regulatory-related matters.
• Advise on regulatory requirements affecting agreements and ensuring compliance.
• Ensure all agreements comply with applicable laws and regulatory standards.
• Draft, review, and negotiate various agreements, including contracts with vendors, clients, and regulatory bodies

Job Type: Full-time

Pay: RM2,300.00 - RM3,000.00 per month

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Puncak Alam: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• REGULATORY AFFAIR: 2 years (Preferred)