Siva Manjith

Q: What is Siva Manjith email address?

Email Siva Manjith at manjith13@gmail.com. This email is the most updated Siva Manjith's email found in 2026.

Q: How to contact Siva Manjith?

To contact Siva Manjith send an email to manjith13@gmail.com. (updated on February 02, 2025)

Head of Quality and Regulatory at ACRA-CUT INC | Hyderabad, Telangana, India

About Siva Manjith

Siva Manjith currently serves as the Head of Quality and Regulatory at ACRA-CUT INC, where he plays a pivotal role in steering the company's quality management systems and regulatory compliance strategies within the biotech and medical device manufacturing sectors. His leadership is instrumental in ensuring that ACRA-CUT’s products meet stringent industry standards such as ISO 13485, FDA 21 CFR Part 820, CE Marking, and MDSAP requirements. Siva’s expertise extends across the development and management of comprehensive eQMS frameworks, facilitating streamlined CAPA administration, risk assessments, and technical file preparations that underpin product safety and efficacy.

A key focus of his role involves managing the complex transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) within the European Union. This strategic initiative demands a deep understanding of evolving EU regulatory landscapes, including compliance with QSR 21 CFR Part 803 and other relevant standards. Siva’s proficiency in conducting thorough risk management, supplier and CMO management, and audit readiness ensures that ACRA-CUT maintains uninterrupted product certification and market access.

His hands-on approach combines technical expertise in manufacturing, statistical process control (SPC), and root cause analysis with a comprehensive understanding of regulatory frameworks. By leveraging his skills in CAD/CAM, finite element analysis, and quality control, Siva ensures that product development aligns with both industry best practices and regulatory mandates. His leadership not only safeguards product quality and patient safety but also drives continuous improvement initiatives that support ACRA-CUT’s strategic growth in a highly regulated environment.

Siva Manjith Work