Hi,
I have an opening with one of my client in Hyderabad (a developer, manufacturer and marketer for advanced molecular pathology systems for cancer detection, bio-medical research, drug discovery and development.
Head RA & QA (Regulatory Affairs & Quality Assurance)
Job Profile:
- To establish and implement Company’s overall compliance policies and strategies to meet business needs
- To oversee the functions of Quality Assurance and Regulatory Affairs to ensure all budget, scheduling, efficiency and objectives are met
- To direct the development, implementation, and maintenance of an effective quality management system to ensure that FDA QSR, ISO 13485, and other relevant quality requirements
- To direct the development, implementation, and maintenance of effective regulatory compliance programs, including FDA submissions, international product registration, product classification and labeling, field corrective actions, and Health, Environmental and Safety compliance, to ensure that all relevant domestic and international regulatory requirements
- An overall experience of 15 – 20 years working in a Quality Management role in a regulated interface, which includes previous interface with FDA
- must be a Bachelor's degree in an Engineering discipline
Should you require more details, please reach MS. Seema at seema@optionsindia.com
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