Executive Regulatory Affair
1 week ago
**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
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)
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