Medical Device Quality Assurance

Sagar D. Pimpalwar

* ******* ******, ******, ** *2120 • 617-***-****, *********.*@*****.***

Objective:

To obtain Regulatory affairs and Quality System position in reputed medical device company

Core Competencies

•Extensive understanding of USFDA Regulatory Processes, in-depth knowledge of submissions, requirements of the US, EU, Canada, Japan, TGA, SFDA, ASEAN and International Agencies

•Ability to compile and organize materials for pre-submission reports and submission for drugs, biologic and medical device

•Comprehensive knowledge of 510(k), IDE, PMA, PMA supplements, Pre-IND, IND, ANDA, BLA, e-CTD, recalls, post-marketing AE reporting, compliant handling and international regulatory submissions

•Through understanding of an ICH, ISO 13485, and product development, design history files

•European Union drug/device approval/registration pathways, Notified Bodies, CE marking and EU compliance requirements

•Profound understanding of the FDA inspection, internal audit, quality system regulation, quality management system, quality policy and regulatory compliance design control, design history files

•Instrument validation through IQ,OQ,PQ and process validation

•Essential knowledge of GXP’s, Informed Consent, IRB submissions and other Clinical trial regulations

•Ability to assist with Form-483 responses and CAPA, audits and study reports.

Education:

Northeastern University Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices

March 2012

Pune University Maharashtra, India

Bachelor of Science in Pharmacy JUNE 2009

Maharashtra state Board of Technical Education (MSBTE) Maharashtra, India

Associates in Pharmacy JUNE 2005

Experience:

Serum Pharmaceutical, India 2007

Regulatory affairs and Quality assurance Intern

•Maintain and ensure documentation in compliance with regulatory requirement in every department

•Ensured requirements in a manner that clearly supports effective Quality Assurance and Quality Control

•Worked with regulators, internal clients and cross-departmental staff to comply with regulatory requirement

•Assisted in organizing Regulatory dossier for Biologic product for domestic and international markets

•Worked on development , implementation, maintaining SOPs

•In-processes equipment validation, process validation

•Spearheaded and coordinated cross departmental activities

•Involvement in planning site audit, site inspection, environmental monitoring

•Testing of raw materials and packaging materials

Graduate Projects:

•Regulated Implantable Medical Device

Researched and presented Regulatory roadmap for domestic and international market pathways for Medical devices

•Regulatory Strategy Development plan

Researched, analyzed, integrated and organized background information and compiled mock submissions viz. pre-IND meeting request, IND for fictional drug, Notice of Intent to submit special protocol assessment and regulatory development Plan for fictional drug

•21st Century Medical Device: Will Regulatory Landscape Be Different?

Illustrated rapidly changing regulatory environment with an advancement in technology in medical device

•Combination product

Established regulatory and clinical trial development plan for fictional combination product at Northeastern University

•Biosimilar Biologics

Identify regulatory roadmap and clinical strategy for fictional cell based biologic product for pancreatic cancer at northeastern University

Technical Skills:

•Certification: Diploma in IT, Center for development of advance computing

•Well conversant with Microsoft Office (Microsoft Word, Excel, PowerPoint)

•Good oral and written communication in English.

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