BHOOMIKA JOYAPPA

adg8wa@r.postjobfree.com

Raritan, NJ 08869

SUMMARY

Hardworking and dedicated regulatory affairs enthusiast knowledgeable about medical device practices and government regulations. Bringing 5 months of Regulatory affairs internship experience (Drugs and Devices) and seeking a Regulatory Affairs Associate position where I can apply my skills/understanding of legislations to keep the company's product compliant for global approval. Ability to manage files for regulatory submissions including assessing audits, evaluating technical data and checking information accuracy for new or modified products. Well-spoken and friendly with top-notch abilities to work in cross functional departments.

SKILLS

Regulatory Affairs: 510(k), De novo, EN ISO 13485, EN ISO 14971, guidance documents, GMP, GCP, FDA QSR 21 CFR 820 (Quality system procedures/Regulations), MDR 2017/745, UDI, Regulatory Strategy.

Electronic Common Technical Document (eCTD): Technical infrastructure, directory structure, submitting an eCTD, components of eCTD, ICH, Electronic submission gateway

Clinical Data Management: Data Collection Strategy, Data Entry, Electronic Data Capture (EDC)

Computer Application packages: MS Word, Excel, and Adobe, Document development & review

Professionalism: Recordkeeping and organizational ability, communication skills, analytical skills, problem solving and attention to detail

EXPERIENCE

Regulatory Affairs Intern / Institute of Regulatory Affairs Education and Training - NJ 02/2020 - 06/2020

Prepared FDA submissions necessary for new product approvals/clearances which include Pre-market notifications- 510(k)s, Investigational Device Exemptions (IDEs) submissions, Pre-Submission requests, including NDAs, INDs.

Prepared and reviewed 510(k) submissions for Cardiovascular intravascular filter and percutaneous catheter devices.

Analyzed FDA warning letter to highlight deficient GCPs and GCPs that were not followed essential in responding to FDA deficiencies requested by the regulatory agencies

Performed all the tasks assigned with minimal supervision

Knowledge on Post Market Surveillance data (PMS Report, PSUR).

Generated Safety Reports, Field alert reports based on guidance provided.

Drafted Q submission to FDA and seek study risk determination for external pressure disk.

Submitted mock pre-Sub request to FDA for significant risk devices.

Drafted Investigational Device Exemptions (IDEs) annual report required by CDRH/FDA.

Reviewed relevant protocols for deficiencies (Risk assessment, patient population, safety parameters, any regulatory reporting etc.).

Devised pre-IND meeting summary information packages.

SAS Programmer III / Janssen Pharmaceuticals Inc. - Raritan, NJ 03/2016 - 03/2017

Implemented, debugged, and validated SAS programs based on SDTM / ADAM guidelines and study requirements.

Executed change requests, complaint handling and issue tracking using JIRA.

Addressed customer requests and issues by establishing workarounds and solutions to debug and create defect fixes.

Streamlined the remediation processes within a time-sensitive environment, ensuring service exceeded expectations for all internal customers.

Identified the root cause for errors and problems in programs and processes.

Performed data analysis as per industry standards mentioned in program specifications document.

Actively involved in writing and updating departmental Standard Operating Procedures (SOPs).

Developed technical solutions for ad hoc projects

Technical Writer / Huawei Technologies Ltd - Bengaluru, India, 04/2011 - 05/2012

Collaborated on all stages of development lifecycle, from requirement gathering to production releases.

Assisted in the writing, formatting, compiling and maintaining documentation, policies, procedures for new products and product modifications that increased departmental productivity.

Translated critical documents in the target language (Mandarin) with care and accuracy.

Effectively collaborated with my counterparts at Huawei HQ to prepare, manage the translation requirements, to get the documents peer-reviewed and tested to ensure compliance in the target market.

Wrote easy-to-understand user interface text, online help and developer guides.

Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.

Software Tester / Global Innova Technologies Ltd - Bengaluru, India, 06/2008 - 06/2009

Debugged code and located root causes of problems by reviewing configuration files and logs.

Prepared defect management, communication, and test scope sections of test plan.

Documented test cases, test plan and conducted peer reviews.

Designed and updated test cases to complete consistent manual tests.

Documented identified defects using JIRA and helped developers complete further testing and resolve issues.

EDUCATION AND TRAINING

City College of New York of The City University of New York - New York

Master of Science: Biomedical Engineering

Coventry University

Master of Science: Advanced Medical Electronics

Visvesvaraya Technological University

Bachelor of Engineering: Information Science and Engineering

CERTIFICATIONS

Regulatory Affairs: Electronic Common Technical Document (eCTD), Biopharma Institute

Adv. Specialist Level Course in US Regulatory Affairs – Drugs and Devices, Institute of Regulatory Affairs Education and Training

Data Management in Clinical Research, Vanderbilt University Authorized by Coursera

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