APAC Regulatory Strategy Lead

Haemonetics; Simpang Ampat; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading global healthcare company in Malaysia is seeking a Regulatory Affairs professional responsible for ensuring compliance across Asia Pacific. The role involves developing regulatory strategies, managing documentation for licenses, and coordinating with various departments. Ideal candidates should have a degree in Engineering or Science, and a minimum of 3 years of experience in a manufacturing environment.

Qualifications

• Minimum 3 years working experience in manufacturing environment.

Responsibilities

• Direct activities to ensure compliance with local regulations.
• Develop and implement all phases of regulatory strategy.
• Provide regulatory authorities with documentation for licenses.
• Establish relationships with external partners and regulators.
• Collaborate with departments to compile tech info for regulatory submissions.
• Review labeling changes for regulatory impact.
• Train employees on regulatory requirements and practices.
• Communicate with customers to respond to regulatory concerns.
• Maintain product registration data base for various regions.
• Manage communication on vigilance issues for assigned countries.

Skills

Problem solving

Root cause analysis

Statistical analysis

Education

Degree in Engineering or Science discipline

Job description

A leading global healthcare company in Malaysia is seeking a Regulatory Affairs professional responsible for ensuring compliance across Asia Pacific. The role involves developing regulatory strategies, managing documentation for licenses, and coordinating with various departments. Ideal candidates should have a degree in Engineering or Science, and a minimum of 3 years of experience in a manufacturing environment.