Job Description

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 Details
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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