Nayarini Estiningsih
Head of Compliance & Operations @electronRx
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WORK HISTORY
Head of Compliance & Operations @electronRx
Cambridge, GB
Regulatory Affairs Quality Assurance ISO 13485SaMD Operations and Project Management
EDUCATION
Central European University
Master, Environmental Science, Policy and Management
Nuclear Engineering National Academy
Bachelor's degree, Nuclear Engineering
Universitas Mercu Buana
Bachelor's degree, Industrial Engineering
The University of Manchester
Master, Environmental Science, Policy and Management
SKILLS
ABOUT NAYARINI ESTININGSIH
Professional Summary:A Quality Management and Regulatory Compliance Professional with Lean Six Sigma Black Belt certification, bringing over 25 years of proven expertise in international medical device (Class I, II, R&D, manufacturing, precision electronics, and automotive environments. Experienced in regulatory and quality management, particularly in overlapping activities, including Medical and Technical File/Design Dossier submissions, DHF maintenance, procedure development, and audit execution.Core Competencies and Attributes:Confident decision-maker with in-depth knowledge of quality management systems (QMS) applicable to modern business practices. Highly numerate, with strong abilities in synthesizing complex data for decision-making support. Fast to learn new, challenging systems, with a solid foundation of formal education across various disciplines. Proficient in quality problem-solving techniques, including Lean Six Sigma and other established methodologies for continuous improvement.Self-motivated and results-driven, with strong leadership and analytical skills. Pragmatic in approach, able to operate effectively across team levels and take on leadership roles as needed. Multi-lingual and culturally aware, with advanced interpersonal skills honed through international business experience, enabling seamless organizational integration.Certifications and Specialties:Specialties: Quality Management, Regulatory Compliance, Risk Management, Change Management, Leadership, Lean Six Sigma.Certified Auditor: ISO 13485, MDD/MDR, MDSAP, ISO 9001, ISO 14001, IATF 16949. Skilled in conducting external supplier audits.
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