Medical Device Management

Srinivas Kondisetti

Email: *****.**********@*****.***

Mobile No: 617-***-****

Multi-faceted, efficient and focused Regulatory Affairs professional with an M.S

in Regulatory affairs from Northeastern University, also having experience of

working in the Regulatory affairs department for Natco pharmaceuticals and

Validation Analyst department at Eli Lilly.

Summary:

• Knowledge on collecting clinical trial data, writing, and filing of 510(k) s,

following with FDA.

• Knowledge on Regulatory submission experience includes IND, NDA, IDE,

and 510(k) submissions.

• Familiar with identification, development and implementation of quality

systems CAPA, Document Control Management systems.

• Working experience on validating EDMS (Enterprise Document

Management system).

• Responsible for authoring initial SOP’s.

• Through understanding of post-marketing activities such as adverse event

reporting system and compliant management systems.

• Extensive experience dealing with Food and Drug Administration (FDA)

regulations such as 21 CFR Part 11 (Electronic Records and Electronic

Signatures), Part 210 (cGMP in Manufacturing, Processing, Packaging and

Holding of Drugs), Part 211 (cGMP for Finished Pharmaceuticals), and Part

820 (Quality System Regulation) and ISO 13485(Medical Devices Quality

management system).

• Thorough knowledge in dealing with Gxp environments like (cGLP, cGMP

and cGCP).

• Knowledge on Global Unique Device Identification Database (GUDID) and

UDI (Unique Device Identifier).

• Familiar with medical device labelling and medical device reporting.

Eli Lilly Pharmaceuticals, Indianapolis, IN

Validation Analyst/Technical Writer Sep’13- Present

Project: Eli Lilly pharmaceutical is one of the leading drug suppliers for diabetes.

My project includes Computer system validation, EDMS and Quality

Management.

Responsibilities:

• Worked on multiple projects, which involves validating the computer

systems, EDMS (Documentum) and active role in quality management.

Created validation deliverables in a system life cycle such as gathering

•

requirements, preparing validation plan, test plan and validation summary

report.

Reviewed the documents like design, security and support SOPs

•

Was responsible for drafting test cases in HPQC 11.

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Prepared system Test scripts and executed them.

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Involved in risk assessment of a system and prepared a risk assessment

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document and facilitated their respective meetings.

Involved in change control management by creating change requests in

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Remedy tool and reviewing them, which is a part of system maintenance

and its postproduction activities.

Prepared requirement traceability matrix (RTM) as a part of SDLC.

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Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11),

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guidelines and internal procedures related to validation of computer systems

and associated infrastructure are followed and applied during all stages of

the defined software development life cycle (SDLC) and project phase

activities

Provided consulting and guidance on the quality and compliance needs

•

during the system life cycle.

Involved in CAPA implementation and respective change control

•

procedures.

Natco Pharmaceuticals, Hyderabad, India Sep’2010 March’2011

Regulatory Affairs Specialist

• Responsible for preparing submissions in paper format and electronic format

using Microsoft word and Adobe acrobat tools.

• Responsible for creating cross-references, Tab sheets, slip sheets, table of

contents, Bookmarks and Hyperlinks.

• Preparing SOPS and process guides for submission process per guidelines.

• Worked on ad-hoc projects which required to work during weekends.

TECHNICAL SKILLS:

• Proficient in MS Office - MS Word, MS Excel and PowerPoint

• Life Sciences: FDA Compliance, 21 CFR Part 11 and SOPs

• Well versed and trained in product development and regulatory issues

involved in New Drug Development, Biologics Development and Medical

Device Development.

• Knowledgeable on Indian regulatory structure and the various regulatory

submissions to DCGI.

• Having good judgment and leadership ability.

• Expertise at browsing the FDA website and searching relevant guidance

documents and CFRs.

EDUCATION:

• MS in Regulatory Affairs for Drugs, Devices and Biologics, Northeastern

University, U.S.

• Bachelor’s in Pharmacy, Jawaharlal Nehru Technological University, India.

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