Dr. Selva

Director-Quality and Regulatory Operations @ SigTuple

About

A Medical Device quality operation and Regulatory professional with 22 years of experience. My core strength lies in conceptualisation, design, and commissioning of Greenfield projects for the Medical device/ Biopharma industry, putting the required quality management systems in place as per cGMP requirements and getting the regulatory approval for the devices ( USFDA 510K clearance, CE marking approvals and other regulated market approvals). Handled End to end-to-end device development and Manufacturing Facility development and regulatory approvals for various Medical Devices, SaMDs , and IVDs

Country

India

City

Greater Bengaluru Area

Industry

Medical Device

Skill

Biotechnology, Lifesciences, Technology Transfer, Cell Culture, Cell, Molecular Biology, Cell Biology, Stem Cells, Manufacturing, Biochemistry, Validation, Healthcare, Biopharmaceuticals, Vaccines, Downstream Processing, Operations Management, Team Leadership, Cross-functional Team Leadership, Team Building, Microbiology

Experience

Director-Quality and Regulatory Operations

SigTuple

2022-10 - Present · 4 yrs

Bengaluru, Karnataka, India

At SigTuple, I head the Quality and Regulatory Team. I am responsible for QMS implementation as per ISO 13485, 21 CFR Part 11 requirements. I take care of the regulatory strategies and the regulatory approval process of our AI-based devices for various markets including the USFDA, EU, India and other emerging markets.

Principal Consultant- Medical Devices QARA Practice

Tech Mahindra

2020-4 - 2022-9 · 2 yrs 6 mos

Bengaluru, Karnataka, India

Here I am overall responsible for the Quality and Regulatory services management for our MedTech Clients. Our team delivers QMS Gap analysis, remediation, QMaaS, Regulatory Consulting of Medical Devices, and IVDs. We cater to various regulated markets including USFDA ( 510k submissions ) and EU ( as per EU MDR and IVDR requirements).

Associate Director - Quality and Operations

LifeSignals Inc

2019-1 - 2020-3 · 1 yr 3 mos

Bangalore

At Lifesignals, I am responsible for implementation of the quality management system as per ISO 13485 requirements across different geographies of the organization, getting approvals for the products in different regulated markets and ensuring smooth operations of different functions as per cGMP requirements.

Vice President - Quality and Regulatory Operations

Axio Biosolutions

2015-8 - 2018-12 · 3 yrs 5 mos

Bangalore , India

• Responsible for implementation of QMS as per ISO 13485:2016 and getting 510K and CE approval for the devices. • Responsible for training the team in MDR Gap analysis • Responsible for overall Manufacturing and Technical operations of the organization. • Responsible for optimization of the manufacturing process and optimizing the product cost. • Responsible for managing the team to deliver the best product. • Responsible for developing the CMOs for Indian and Global Markets. • Responsible for development of new products in the haemostatic and wound care segment.