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Wipro BPO Philippines Ltd., Inc.

Regulatory Compliance Officer

Wipro BPO Philippines Ltd., Inc.

With business certificates
Established in 1945 | 10,000+ employees
G/F Cebu IT Tower One across Ayala Center Cebu and Pag-IBIG Building, Cebu City, Cebu
Total vacancies for this job title : 1
Posted on : April 29, 2020
Job ID : 358314


Wipro Ltd. is a leading Information Technology, Consulting, and Business Process Services company that delivers solutions to enable its clients to do business better. Wipro delivers winning business outcomes through its deep industry experience and a 360 degree view of "Business through Technology" - helping clients create successful adaptive businesses. A company recognized globally for its comprehensive portfolio of services, a practitioner's approach to delivering innovation, and an organization wide commitment to sustainability, Wipro has a workforce of over 174,000 serving clients in more than 175 cities across 6 continents.
Job Description:
  • The regulatory compliance manager develops, implements, and oversees the quality assurance and regulatory compliance strategies of the company.
  • He also monitors and audits the quality ratio according to the standards prescribed. The regulatory compliance manager initiates development of standard operating procedures and ensures whether trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes, and regulations.
  • He also identifies training and educational needs regarding compliance and manufacturing practices and make recommendations.
  • The regulatory compliance manager develops and monitors programs to ensure compliance with several acts and regulations in conformance with industry standards.
  • Experience in components of Medical device/drug surveillance.
  • Understanding of regulatory requirements of Medwatches for reporting post- marketing products, understanding of 21 CFR
  • Knows how to summarize adverse events reports are collected by FDA
  • Knows how to write the CAPA process and complete closer to the actions.
  • Graduate of any Discipline
  • Preferred 3-4 years of experience in the compliance field or about 5-6 years in the management section in the same industry pertaining to quality standards and regulation procedures.
  • Good knowledge of legal requirements and procedures.
  • Brilliant oral and written communication skills.
  • Highly analytical with strong attention to detail.
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