Medical Device Quality

QUALITY AND REGULATORY AFFAIRS PROFESSIONAL

Registered Indian pharmacist completed master's degree in Regulatory

Affairs with four years of Pharma and Medical Device industry experience

seeking for a suitable employment.

FDA and EU regulations PMA and 510 K Pharmacovigilance

submissions

Regulatory submissions Recall management Medical Device Reporting

Argus Database

Track wise Database Agile Database

21 CFR 820 CAPAs, RiskMAPs Quality Systems

Regulation

ICH guidelines SOPs and labelling Design controls

FMEA changes REMS

ISO 13485 Risk Analysis MAUDE Database

MS Access ISO 14971 MS Excel and Outlook

MS Power point

KNOWLEDGE AREAS

PROFESSIONAL SUMMARY

. Registered Indian pharmacist with MS in Regulatory Affairs for drugs,

biologics and medical devices.

. Understanding of US and International regulatory strategies for pre/post

market regulatory submissions.

. Understood and gained knowledge for the medical device reporting (MDR)

and recall management.

. Understanding of regulatory strategy preparation and submission for

510K, IDE, PMA and technical file

. Understanding of 21 CFR 820, EMA directives, ISO 13485, ISO 14971 and

ICH guidelines.

. Worked as a bridge between company and regulatory authority for

internal/external regulatory activities

. Participate in, and contribute to, Health Risk Assessments (HRA);

Supports risk assessment activities.

. Coordinate with company's internal and external departments to foster

regulatory activities.

. Conducted market research to analyse medical devices and their trends as

per MAUDE

. Review and compile regulatory documentation, technical files and design

history file.

. Accurately enter and maintain data into the designated post market

surveillance database.

. Develop internal systems, methods and processes to maintain compliance

support post-market activity

. Expertise for handling various safety databases such as Track wise, SAP,

Oracle, ARGUS, Agile etc.

. Excellent ability to review and interpret technical documents,

professional journals and regulations.

. Understand, interpret, analyse and clearly present scientific and

medical data.

. Excellent written and verbal communication skills as well as highly

professional presentation skills.

. Excellent IT skills and Proficient with Microsoft operating systems,

SharePoint.

. Knowledge of MS Outlook, MS Word, MS Power Point, MS Excel, MS Paint, MS

Access, Adobe tools.

EXPERIENCE

Quality Engineer

Philips, Andover, MA June 2013- Present

. Accurately entering and maintaining data into the designated post

market surveillance database.

. Develop internal systems, methods and processes to maintain compliance

support post-market activity

. Coordinating with different departments such as R&D, validation

services, clinical affairs and production

. Identifying complaints that represent further evaluation under 21 CFR

Part 803 (MDR).

. Identifying and report any quality/compliance concerns and take

immediate corrective action as needed

. Reviewing and submitting regulatory reports within the timeframes

mandated by the regulatory authority

. Complete assigned investigations from initial receipt of complaint to

identify the root cause and closure.

. Reviewing and evaluating service event data for medical device

products to verify complaint criteria.

. Receiving and documenting product events reported by customers and

field Service Engineers.

. Coordinating and requesting additional information as needed for

complete understanding of the event.

. Participate in, and contribute to, Health Risk Assessments (HRA);

Supports risk assessment activities.

. Coordinating in Medical Device Reporting (MDR) and Adverse Event

Reporting (AER) activities.

. Supporting the Quality Audit activities including audit and inspection

preparation.

. Completing investigations in a timely manner as per defined metrics

for class I and II medical devices.

Regulatory Affairs Associate

Source Production and Equipment Co. Boston, MA

Sep 2012- June 2013

. Evaluate, archive and create design controls, risk analysis and CAPA

for 510K submissions.

. Worked and gain knowledge for Traditional and Special 510 K procedures

for Class II Medical Devices.

. Reviewed and compiled regulatory documentation, technical files and

DHF per 21 CFR 820, ISO 13485

. Reviewed and modified department procedures as necessary to stay

current with corporate standards.

. Established Risk Management files, including, designing FMEA as per

company SOP's and ISO 14971.

. Supported QA/RA Vice President in development and maintenance of the

Quality Management System

. Supported Marketing, R&D and Manufacturing teams in regulatory

assessment of proposed changes.

. Investigated and developed a regulatory and marketing analysis for

U.S. and international approvals.

. Completed and submitted regulatory reports within the timeframes

mandated by the regulatory authority

Regulatory Affairs Intern

Regulatory Doctor, Boston, MA

Jun 2012 - Sep 2012

. Assisted in Preparation and developing a market strategy for PMA

submission for combination product.

. Conducted market research to analyse medical devices and their trends as

per FDA-MAUDE database.

. Understood for the post market surveillance, adverse event reporting and

recall of medical devices.

. Promulgated internal regulatory inputs by assessing the new regulations,

guidelines and laws

. Reviewed technical publications and articles to stay abreast of

regulatory developments in the industry.

. Assisted in the complaint program as required and supported in SOP

development activities.

Regulatory Affairs/ Quality Intern

AblaCor Medical Corporation, Boston, MA Mar 2012

- Jun 2012

. Collected and compiled regulatory and market data survey for domestic

and international market.

. Investigated and analysed the competitor products and regulatory

requirement for PMA approval.

. Participated as a member of a product development team to provide

regulatory support to the project.

. Evaluated and investigated post-market incident reports and

determination for MDR requirements.

Pharmacovigilance Officer

Wipro Private Ltd., Greater Noida, India

Mar 2011 - Aug 2011

. Reported adverse events in accordance with current FDA regulations and

given company SOP's.

. Prepared, entered and maintained case reports data via Pharmacovigilance

Safety Database.

. Prepared case narratives and triaging of the incoming reports for

completeness, legibility and validity

. Complete and submit regulatory reports within the timeframes mandated by

the Regulatory Authorities.

. To report Suspected Unexpected Serious Adverse Reactions to Health

Authorities and investigator.

. To reviewed literature screening search results, identifying ICSRs and

other safety-related findings.

. Understood, interpreted, analysed and clearly presented scientific and

medical data.

. To conduct Individual Case Safety Report (ICSR) and perform quality

control activities (QC).

. Assisted with recall/retrieval documentation and other activities.

Pharma Associate

CARING Foundation, Delhi, India

Mar 2010 - Dec 2010

. Volunteered for educating poor, illiterate, women and children for drug

abuse and medications errors.

. Assisted in Pulse Polio immunisation campaign during two National

Immunisation Days (NIDs).

. Served in a free clinic campaign for the people without other health

care options.

Territory Manager

Himalaya Healthcare India Ltd., Delhi, India

Jun 2008 - Feb 2010

. Collected and submitted post market surveillance data and gave regular

feedback from/to HCP's.

. Implementation of field strategies and remedial actions with the

feedback from healthcare professionals

Associate Industrial Trainee

Windlas Biotech Ltd., Dehradun, India

Mar 2007 - Aug 2007

. Worked on quality system, manufacturing controls (CMC) and its

specifications as per ISO 9001.

. Performed Inspection, sampling and laboratory tests or examinations to

ensure the functioning.

EDUCATION

MS Regulatory Affairs for Drugs, Biologics and Medical Devices

GPA- 3.52

Northeastern University, Boston, MA

Mar 2013

Awards: ISSI Retention Fund Scholarship Award; CPS International Student

Scholarship Award, 2012

Bachelor of Pharmacy

Uttar Pradesh Technical University, Lucknow, India

Jun 2008

Awards: "Best Student Award" 2008, Head of Student Placement Committee,

Cultural Committee Head.

PROJECTS AND PRESENTATIONS

. Presented a traditional 510k strategy plan for Surgical Staplers in

class settings, Dec, 2012

. "Perspectives on challenges and proposed solution in Indian healthcare

system" in Aug, 2012.

. Strategy for PMA submissions for drug eluting stents in June 2012.

. Presented a traditional 510k Plan for bone cement for spine fractures,

May 2012.

. "Food Drug Administration and European Union" comparison on clinical

trial and regulatory prospective

. Prepared and presented a position paper on "Clinical Trials Outsourcing:

Good or Bad?" in Mar 2012

. Presented a project on "Overview of Quality Management Systems: ISO,

cGMP and Q-10" in Nov 2011

. Conducted seminars and presentations on Cosmetology and their

Preparation and in 2008.

. Completed and submitted a project on Hypertension and "Feverfew" drug in

2008.

CERTIFICATES ACHIEVED

. Presented and participated "Pharmacovigilance in Public Health" workshop

conducted by Uppsala

Monitoring Centre and Empower School of Health in November 2010 at New

Delhi, India.

. Conducted Continued Medical Education seminars for physicians and HCP at

Delhi, India in 2009-10.

. Presented seminar in IPGA welfare trust on national Pharmacy week in Dec

08 at Greater Noida, India

. Conducted seminars and presentations on Cosmetology and their

preparation; Hypertension; Feverfew.

PROFESSIONAL MEMBERSHIPS

. Regulatory Affairs Professionals Society (RAPS).

. Medical device Group (MDG).

. International Student and Scholar Institute (ISSI).

PAPER PUBLICATIONS

. Published a Review article "Food Drug Administration vs. European Union"

in Drug Designing

Journal available at,"http://www.omicsgroup.org/journals/2169-0138/2169-

0138-2-105.pdf".

. Published a Review article "Clinical Trials Outsourcing: Good or Bad?"

in Drug Designing Journal

available at, "http://www.omicsgroup.org/journals/2169-0138/2169-0138-2-

104.php?aid=11759.

. Published a Review article "Liposomes as a Drug Delivery Carriers- A

review" in International

Research Journal of Pharmacy at

http://www.irjponline.com/admin/php/uploads/first-issue/5.pdf

. Published a Research article on "Preparation and Evaluation of Floating

Tablet of Famotidine

Through Solid Dispersion" in International Journal of Contemporary

Research.

VOLUNTEER EXPERIENCE:

. Student Volunteer

Boston, MA

Medical Development Group

May 2012-Present

Aug 2012- Present

. International Student Leader

Boston, MA

ISSI, Northeastern university

Nov 2011- Present

. Co-Chair Carnevale Committee

Boston, MA

International student and scholar institute

Sep 2012- Present

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