Medical Device Quality

SHRADDHABEN SATASIYA

*** ******** ******, *****, ** - 02468 718-***-**** ****************@*****.***

QUALIFICATION SUMMARY

• Highly motivated and enthusiastic Regulatory Affairs professional with thorough understanding of regulatory

approval procedures and quality documentation required throughout the life of pharmaceutical products.

• Profound knowledge of CGMP, ISO, QSR, MDR and global regulatory framework (FDA, EMA, TGA and

Health Canada) allowing me to play key role in maintaining regulatory documentation in medical device industry.

• An individual with strong communication and documentation skills with an ability to work in a cross-functional

team environment to satisfy both internal and external stakeholders.

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EDUCATION

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Northeastern University (NEU) Boston, MA

Masters of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices (GPA – 3.72)Sep. 2013- Mar. 2015

Coursework: Introduction to Drug and Medical Device Regulations; Emerging trends and issues in medical device

industry; Advertising and promotion of drugs and medical devices; Canadian/Australian medical device

regulation; Food, Drug & Medical Device Law; Drug/device Supplier Risk Management; Human

Experimentation: Methodological Issues fundamental to clinical trials; A QA/Regulatory overview of New Drug,

Biologics and Medical Device Development; Global Biotechnology Product Regulation.

Gujarat Technological University Gujarat, India

Bachelor of Science in Pharmacy (GPA – 3.80) Jun. 2008- Jun. 2012

AWARDS AND HONORS

International Scholarship for the study of International Regulatory Affairs for the spring term, NEU Apr. 2014

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International Scholarship for the study of International Regulatory Affairs for the fall term, NEU Sep. 2014

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PROJECTS AND PRESENTATION

Developed risk management plans, validation report, and Corrective and Preventive Action (CAPA) for a virtual

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product as part of Drug/Device supplier risk management course. Northeastern University, Boston Mar. 2015

Formulated SOP for Supplier Selection Qualification. Northeastern University, Boston, MA Feb. 2015

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Outlined the influence of social media on Advertising and Promotion of Drugs and Medical Devices. Group project

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and presentation at Northeastern University, Boston, MA Dec. 2014

Demonstrated the use of 3D Imaging technology in manufacturing customized patient specific replacement

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implants. Northeastern University, Boston, MA Nov. 2014

Outlined the importance of Emerging regulations and issues faced by the FDA for mobile medical device and

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wearable medical devices. Oral presentation at Northeastern University, Boston, MA Jul. 2014

Developed a Canadian license application form for a fictional medical device as per the Canadian license

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submission guidelines Jun. 2014

Corrective and Preventive Action (CAPA) – The quality regulation to rule out the nonconformity from the system.

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Oral presentation at Northeastern University, Boston, MA Feb. 2014

WORK EXPERIENCE

Nascent Lifescience Pvt. Ltd. Ahmedabad, India

Quality Assurance and Quality Control Executive Jun. 2012 - May 2013

• Maintained quality documentation throughout the production process to ensure that the manufacturing processes

and changes are in accordance with the ISO 9001:2008 and CGMP quality standards.

• Responsible for the documentation of deviations and incident reports, product specification and release reports.

Efficiently managed post marketing complaint database for conducting safety analysis of marketed products.

Shraddhaben Satasiya

Efficiently verified and validated end products as per SOP requirement and prepared batch product report and

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annual product quality report to ensuring consistent quality in accordance with company standards.

Responsible for in-process inspection of drug production, and retrospective inspection of production documents to

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ensure adherence to ISO 9001:2008 and CGMP standards.

Assisted in developing SOPs; initiate trainings for new SOPs and maintain the training records in accordance with

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company and regulatory standard.

Coordinated and assisted in internal audits to determine the in-process quality standards. Participated in external

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audits and assisted in responding to findings resulted from external audits.

Coordinated and assisted with the preparation of regulatory documentation and submission for domestic and

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international project approval process.

Leo Formulations Pvt. Ltd.

Ahmedabad, India

Intern Quality Control/Quality Assurance Jun. 2011 - Jul. 2011

• Performed Quality Control tests like Leak test, Friability test and Stability test for solid dosage forms in CGMP

work environment.

• Performed documentation, organization and archival of the production documents in accordance with regulatory

requirements.

• Participated in educational training required in accordance with standard operating protocols (SOPs).

• Organized and formatted the documents in accordance with the CGMP requirements.

• Responsible to handle agency confidential documents and review existing protocols.

OTHER WORK EXPERIENCE

Northeastern University

Boston

Resident Safety Officer – Proctor (Part time) Dec. 2013 – Mar. 2015

• Responsible for maintaining strict discipline in the hostel and provide guidance to incoming students and visitors.

• Document and record student complaints, access the severity of the complaints and take the appropriate steps

required.

• Document and maintaining visitor logs as per the security protocols.

• Assisting in admission and registration of the hostel accommodation facilities for the students

SKILLS

Regulatory Skills: Proficient in SOP development, developing and implementing risk management plans, and CAPA

system. Well-equipped with regulatory documentation required under FDA, EMEA, PMDA, Health Canada and

TGA regulations. Profound knowledge of MDR reporting (Form 3500A), IDE, 510(k), PMA, QSR, ISO 9001 and

13485, design/process verification and validation, as well as documentation for process change. Well versed with

regulatory requirement under 21 CFR 210, 211, 312, 314, 803, 810, and 820.

Documentation Skills: Organization and archival of production records, cleaning log books, batch process reports and

Annual Product Quality Report (APQR) in accordance with regulatory and company policies. Revising SOPs and

maintaining training records. Maintain complaint database and reporting as per regulatory requirement.

Technical Skills: Proficient in MS-Office tools (Word, Excel and PowerPoint), SmartDraw, Outlook, and SharePoint.

Developed beginner’s proficiency with Microsoft Project management.

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Shraddhaben Satasiya

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