Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Haemonetics

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

Job Responsibilities

• Initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products / services.
• Provide regulatory authorities with appropriate documentation to obtain licenses and regulations.
• Establish and maintain relationships with external partners, regulators and opinion formers; follow regulatory activities at local level.
• Work with corporate RA, R&D, Marketing, Legal, Business Leader, and other relevant distribution departments 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 database 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

Senior Level

Mid-senior level

Employment Type

Full-time

Job Function

Legal

Industries

Hospitals and Health Care and Medical Equipment Manufacturing

Location

Batu Kawan, Penang, Malaysia

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