Senior Regulatory Affairs Specialist

4 days ago

Batu Kawan, Penang, Malaysia Haemonetics Full time

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

EEO Policy Statement

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