Senior Regulatory Affairs Specialist

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

Job Details

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Summary:

Responsible for directing activities to ensure compliance with local regulations within Asia Pacific countries.

Job Responsibilities:

• Responsible initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services.
• To provides regulatory authorities with appropriate documentation in the aim of obtaining licenses and regulations.
• To Establishes and maintains relationships with external partners, regulators and opinion formers. Responsible for following regulatory activities at local level.
• Responsibilities encompass to work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant distribution department to compile technical information for supporting regulatory submissions for the countries of the region.
• Review proposed labeling changes to determine regulatory impact on existing certifications and registrations.
• Work with RA staff, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization.
• Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
• Review new regulatory guidance and participate in the implementation of programs to support compliance
• Communicate with customers to respond to regulatory concerns/questions.
• Maintain product registration data base for Hong Kong, Taiwan, South/East Asia and India Subcontinent & Distribution countries track regulatory department metrics
• Manage communication about vigilance issues for assigned countries.

Job Requirement:

• Degree in Engineering or Science discipline or equivalent
• Minimum 3 years working experience in manufacturing environment
• Knowledge in problem solving, root cause and statistical Analysis

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