1. RAGHAVAN NAIR ASOK KUMAR
rasokkumar@gmail.com
Mobile: +91 9582150686
Quality Assurance ~ Regulatory Affairs ~ Manufacturing Practices
Verticals: Medical Devices, Healthcare and Pharma
ABRIDGEMENT
 A perceptive outcome oriented proficient professional with Graduation in Chemical Engineering supported by
30 years of expertise at the functional area of Quality Assurance, Regulatory Affairs thru Operation in the pasture of
Medical Device & Healthcare Industries.
 Conscientious and Scrupulous compassionate on Medical Device regulation practices, procedures and pertinent
guidelines.
 Lead Auditor, erudite for handling of ISO audits conformance to Regulatory Standards as well as to basis Newfangled
Qualification based on compliance with Acceptance Criteria.
 Proficient in Managing & Streamlining Systems with proven ability to enhance operational effectiveness,
productivity with regards Cost, Time & Quality deliverables.
 Hands on experience in Process Validation thus to assure consistent production complying targeted specification.
 Pertinent Individual who confers with the higher up individuals on the corporate level with positive traits with
exceptional conversational skills; comfortable interacting with multiple levels of organisation, management and staff
from different locations.
KEY SKILLS:
 QA & RA for Medical Devices 
 Good Manufacturing Practices for Medical Devices manufacture, GxP 
 Strategic Planning 
 Setting up of green field manufacturing unit 
 ISO 9000, ISO 14000, ISO 13485 
 EC/HC/TGA requirements for medical devices 
 Project Implementation from conceptualization to commercialization 
 People Developer Standards 
 Quality System Auditing 

2. SCHOLASTICS:
 Bachelors Degree in Chemical Engineering (1984), Annamalai University.
 Completed Lead assessor course for Quality system audit as per the requirement of ISO 9000-1994
 Completed Lead Assessor course for quality system audit as per ISO 9000-2000.
 Completed ISO 14000 Lead auditor course from BVQI
PROFESSIONAL ENHANCEMENTS:
 Member of National Institute for Quality and Reliability
 Member of the Indian Institute of Chemical Engineers
PROFICIENCY SYNOPSIS:
Quality Compliance:
 Ensure implementation of Quality Management System through-Quality Manual, Quality Objective, Quality Policy,
SOP, Standard Test Procedure, Work Instruction etc – hereby assure correct procedures are consistently followed
at each step in the Manufacturing process
 Indoctrinate ethnicity for World Class Manufacturing Quality during the manufacturing process itself neither testing
the devices afterwards by controlling Quality, Safety and Efficacy of the devices.
 Establishing system while ensuring products are consistently produced and controlled per Quality and Regulatory
Std.
 Ensure to maintain of Device Master Records, Device History Records starting from Incoming to Finished product.
 To investigate Out of Specification (OOS), Out of Trend (OOT) & approval for the same.
 Analysis of Customer Complaints, providing Corrective & Preventive Action (CAPA) against Root Cause Analysis
(RCA).
 Review and approval of Stability Study to ensure on-going Stability.
 Responsible for Systems Audit, Deviation & Change Control, Periodic Review, and Sign off Technical Agreements.
 Controlling of all Quality Documents for Retrieval, Issue and Retention as per Document Management System.
Qualification & Validation:
 To review and approve of all Qualification Documents and ensuring compliance of DQ, IQ, OQ and PQ.
 Preparation of Master Validation Plan and thus to accomplish Cleaning Validation, Process Validation, Analytical
Validation
Audit Management:
 Certified Lead Auditor from BVQI on Quality Management System.
 Aspiring zilch for non-conformity during Pre-Assessment Audit, Second Party Audit, Third Party Audit, Unannounced
Audits, Gap Analysis, Due Diligence Assessment for the site.
Supplier Quality Assurance:
 Up surge existing vendors while evaluation anchored on Quality, Cost, Timely Delivery & periodic audit at site.
 New Vendor Development based on Sample evaluation, followed by Quality Questionnaire and finally plant audit.

3. Quality Management System:
 Establish, document, implement and maintain effectiveness of Quality Management System in accordance with;
 EN ISO 13485: 2012- Medical devices -Quality Management Systems -Requirements for Regulatory Purposes
 ISO 9001:2008- Quality Management Systems Requirements
 ISO 14001:2004-Environmental Management Systems-Requirements with guidance for use
 ISO 14971: 2007-Medical devices-Application of Risk Management to Medical Devices

Regulatory Affairs:
 Obtaining CE Marking on product guided by Medical Device Directive resulting of Technical File.
 Annual keep up of all regulatory certifications through compliance of audit, endow with requisite documents.
 Ensuring effective and prompt reply using supplements & variations for filing Post Approval changes.
 Submission to Marketing Authorization Applications for Indian market.
 Imparting Training to team members to keep them abreast about regulatory updates.
PROFESSION OUTLINE:
JOHNSON & JOHNSON MEDICAL INDIA LIMITED Sep 2013 till date
“Vice President (Quality Assurance & Regulatory Affairs)”
Responsibilities:
 Responsible for Quality Assurance and Regulatory Affairs of Johnson & Johnson Medical India(JJMI)
 Lead and provide expert advice in Quality System Management. Develops and implements global strategic
initiatives for quality system. This includes reviewing and monitoring all quality metrics from customer complaints
to manufacturing discrepancies to Top X issues. Working with international cross-functional teams to determine
root cause and implement appropriate corrective actions
 Maintaining product quality metrics. Formulating new or revised procedures to effect improvements, reduce costs
and enhance efficiency.
 Champion quality improvement initiatives and work closely with other key functions to
1) monitor customer feedback and perceptions of product and service quality;
2) implement substantive quality improvement initiatives designed to improve customer satisfaction of
JJMI products and services
 Prepares and conducts Quarterly Quality Management reviews for Executive Management Staff providing global
cohesive action plans and driving corrective actions throughout the organization.
 Drives Indian Registrations and Approvals to optimize timeline and support strategic direction
 Directs and manages the QA department to ensure the optimum performance of all functions
 Determines the staffing requirements of the QA & RA department and trains and develops departmental
employees.
 Implements techniques to improve productivity, increase efficiency and reduce costs.
 Serves as one of the company’s key contacts during regulatory agency inspections. Responsible for interactions
with Bureau of Indian standards and representative of JJMI in the committees
 Responsible for interaction in all Industry associations, representative of JJMI in these associations
 Member of the Management Board of Johnson & Johnson Medical India

4.  Responsible for customer complaint investigation techniques, vigilance handling, corrective and preventative
action analysis.
 Timely and effective regulatory approvals per Product Roadmaps. Identifying root causes and driving the
responsible groups towards implementing corrective actions.
 To support of manufacturing, engineering, customer services, marketing, and sales channels worldwide.
Attainments:
 Developed and implemented regulatory strategy for zero disruption
 Reduced the cycle time of registration to 30%
 Implemented ISO 13485 and obtained Certification from BSI.
 Involved in the development of Schedule MIII for medical devices
 Involved in the development of Medical Device rules by CDSCO
 Representative of India in the Asian Harmonisation Working Party
 Regulatory co chair for Confederation of Indian Industries, responsible for dialogues with the
Govt on all regulatory Policy matters
 Member of core committee of the Medical Technology Association of India
PRECEDING ASSIGNMENTS:
COVIDIEN HEALTHCARE INDIA Apr 2009 to Aug 2013
“Director (QA- Asia)” Covidien Healthcare Pte. Singapore – Reporting to Sr.Director Asia
“Head (QA/RA)” Covidien Healthcare India – Reporting to Director RA & QA
Responsibilities: Director (QA - Asia)
 Responsible for Quality Assurance function for Asia
 To foster quality culture in the organization.
 Maintaining close interactions with Asia teams for inputs on Quality and feedback on performance.
 Ensure periodic Audits to Support compliance.
 To direct, implement, and maintain of an effective ISO 9001 & ISO 13485 QMS throughout Marketing companies
in Asia.
 Responsible for PMS of all Covidien Products
 Responsible for validation of critical processes and revised processes.
 To ensure processes & products conformance through planned quality audits.
 Drive change initiatives to improve compliance and quality management system.
 To establish & implement overall compliance policies / strategies to meet business needs.
 Keep an update on latest international harmonized standards & product standards, and ensure product
conformance accordingly.
 To increase the effectiveness of the quality circles.

5. Responsibilities: Head QA/RA- Indian Subcontinent
 Develop Regulatory and Quality Strategy for Covidien Healthcare India Pvt Ltd
 Execution of the Regulatory Strategy and timely registration of New Products in medical device and
pharmaceutical Global Business Units
 Management of Incident Reporting/PMS
 Responsible for quality system implementation
 Play pro-active role in various industry bodies like CII, FICCI and influence regulatory policies
 Improve Company brand among the various regulatory departments.
 Team member of localization of products-country specific products
 Team member of local manufacturing acquisition.
 Member of India management team and reporting to QA&RA Director - APAC
 To ensure that all relevant domestic and international regulatory requirements are met.
 To coordinate & communicate with notified bodies for effective regulatory compliance, product registration,
Technical documentation, corrective actions, and Risk Analysis.
Attainments:
 100% First Pass Yield of all product registrations in the last one year
 Successfully registered 140 products in FY 2010 in Indian Sub Continent.
 Recipient of Exceptional Employee Award – 2010
 Heading the APAC project for the improvement of Product Incident Reporting.
RELISYS MEDICAL DEVICES LTD, HYDERABAD Oct 2008 - Mar 2009
“Senior Vice President, Works & RA –– Reporting to Managing Director”
Responsibilities:
 Managed entire works at Hyderabad having 90 employees.
 Responsible for ISO 13485 accreditation and CE
 Responsible for regulatory approvals with Drug controller General of India, USFDA and all registrations in different
countries
 Ensure periodic Audits to Support compliance
 Perform in accordance with sound business ethics, purchasing and supply standards, policies and procedures to
give organization the highest possible perceived integrity in all relationships.
Attainments:
 Successfully executed manufacturing project and validated processes of Cardiac stent
manufacturing
 Achieved 4 class III product registrations in CDSCO
 Initiated 3rd party review for USFDA approval

6. VASCULAR CONCEPTS, BANGALORE Sep 2007 - Oct 2008
“General Manager, Manufacturing & RA”
Responsibilities:
 Responsible for two manufacturing operations each in India and Thailand.
 Managed Indian Regulatory affairs
 Responsible for New Product Development
 Responsible for expansion of the manufacturing facility
Attainments:
 Improved capacity utilization from 80% to 93%
 Achieved ISO 13485 certification
 Successfully received CE for drug coated stents
 Received 4 product registrations within a year
HINDUSTA N LATEX LIMITED (NOW KNOWN AS HLL LIFECARE LTD) Nov 1985 - Sep 2007
Growth Path:
 Mar 2004 – Sep 2007 DGM, Strategic Planning & Head of Vaccine / Pharma SBU, Trivandrum
 2001 – 2004 Assistant General Manager, Corporate QA & Management Representative
 1998 – 2001 Manager – Production & QA and Deputy Unit Chief of Medical Manufacturing unit
 1991 – 1998 Manager – QA
 1989 - 1991 Sr. Asst Plant Manager (Projects)
 1987 - 1989 Asst. Plant Manager
 1985 - 1987 Executive Trainee- Expansion project
Responsibilities: DGM, Strategic Planning & Head of Vaccine / Pharma SBU, Trivandrum
 Responsible for Strategic Planning (5 years) of the company.
 Prioritizing of projects to achieve the goal of 5X – i.e. from Rs. 200 crore to Rs. 1,000 crore revenue
 Budgeting yearly operation plan and monitoring performance
 Development of Detailed Project Report (DPR) for in-organic growth opportunities
 Responsible for R&D tie-ups with national and international research centers
Achievements:
 In partnership with E&Y finalized the strategic plan to grow 5X – focus areas were Women Health
Pharma, Vaccines & Pathological Labs
 Developed blue print for Women Health Pharma (WHP) project, executed the entry strategy,
managed the commercial operation for a year and then handed over on a Build, Operate &
Transfer model
 Introduced 12 WHP products in the first year of operation.
 Developed blue print for Vaccines project, executed the entry strategy, managed the commercial
operation for a year and then handed over on a Build, Operate & Transfer model.

7.  Introduced Japanese encephalitis vaccine SA-14-14-7 in India for the national immunization
program.
 Entered into an MOU with Atlanta Medical University, USA and with a Bio-tech company in San
Diego, USA for vaccine research.
 Developed blue print for Pathological Testing Services (Hind Labs) project, executed the entry
strategy, managed the commercial operation for a year and then handed over on a Build,
Operate & Transfer model.
 On behalf of Ministry of Health & Family Welfare, Government of India developed a project
proposal for setting up a Medical Device park at Chennai by utilizing the 350 acres of excess land.
 Completed due-diligence in partnership with SBI CAPS for acquiring a condom manufacturing
plant
 Short-listed 5 IUDs from China, coordinated a visit of an expert committee constituted by the
Ministry for finalizing to introduce it in National Family Welfare Program of India
 Was one of the two industry representatives for IUD working group in WHO in developing the
standards for IUDs and participated their IUD review meeting in Geneva
 Involved in the Negotiations with Trade Unions on the long term settlement as well as Yearly
Bonus discussions.
Responsibilities: Assistant General Manager, Corporate QA & Management Representative
Achievements:
 Received CE mark for 2 class III and 3 class II medical devices in first pass from SGS Yarshley,
UK
 Received ISO 13485 & ISO 18000 accreditation for all the 3 manufacturing units of the company
having 2200 employees.
 Successfully completed WHO pre-qualification audit for the Oral Contraceptive formulation unit
(hormone processing) and Bulk drug plant (ormeloxifene)
 Initiated the Customer Service Group and formulated customer satisfaction Index.
 Quality Function Deployment concept was institutionalized throughout the company.
 Initiated Six sigma and completed first phase of SQC training to all officers
 Handled about 15 external quality audits with no major Corrective Action Report in Medical
Device and Pharmaceutical
 Was a member of the core committee, set up by ICMR and Dept of Science & Technology for the
development of Medical Device regulation for India (Medical Device Safety bill), under the
chairmanship of Dr.Valliyathan.
 Received the Golden Peacock National Quality Award.
 Implemented People Developer Standards throughout the company.
 Completed product registrations in USA, Netherlands, Turkey, African continent, Brazil, Peru,
Venezuela, Chile & UK

As Manager – Production & QA and Deputy Unit Chief of Medical Manufacturing unit
Achievements:
 Achieved 100% capacity utilization from 40%, within a year of taking over as head of Production
and QA.
 Set up a green field Suture manufacturing plant and achieved 80% capacity utilization within first
year of operation.
 Successfully headed the project for development of tissue expander through in house R&D
 Finalized the Job grade fixation, Yearly bonus scheme for the plant.
 Was responsible for negotiations with Labour Unions (4 unions) and was successful in settling all
the issues.
 Was the Deputy Unit chief of the plant having 300 employees

8. As Manager – QA
Achievements:
 Developed and maintained the unit as per the requirements of CFR 21 – 820 cGMP.
 Responsible for regulatory affairs of the medical device unit producing Copper T,Blood bag,
Hydrocephalus shunt
 Responsible for regulatory audits and audits by different country health authorities at the time of
registration.
 Coordinator of the UNFPA project funds and implementation.
 Formulated QA systems and SOPs and was in line with the requirements of USFDA CFR 21- 820
requirements.
 Designed the clean room for medical device production
1989 - 1991 Sr. Asst Plant Manager (Projects)
1987 - 1989 Asst. Plant Manager
1985 - 1987 Executive Trainee- Expansion project
REPRESENTATIONS:
a. Expert member in TC 157 of the ISO Technical committee for Mechanical contraceptives representing India.
b. Member of the Obstetric and Gynecological Instruments and Appliance Sectional Committee, The Bureau of
Indian Standards.
c. Member of the Task force constituted by the Govt. of India to review the standards of contraceptives in India.
d. Member of the committee to formulate the Medical Device Good Manufacturing practices for the Govt. of
India.
e. Member of the Committee constituted by the Govt. of India for formulating the standards for the Intra Uterine
device Copper T 380A.
f. Member of the Task force working in the formation of Indian Medical Device Regulatory Authority constituted
by ICMR.
g. Coordinator for Indo China collaboration in Reproductive Health and Family Welfare in identifying technologies
suitable for transfer to India.
h. Member of the Certification audit team of NQA-QSR for the certification of one Foundry, an Educational
Institution and one Medium Scale Chemical Industry for ISO 9001- 2000.
i. Member of the core group formed by the Drug Controller General of India to formulate the medical device
regulation and implementation in India.
j. Member of working group WG 2, WG 3 & WG 4 of the Asian Harmonization Working Party
k. Representative of Indian Industry in the Asian Harmonisation Working Party
PAPERS PRESENTED
 Presented a paper on Packaging of Medical Devices & Accelerated Aging Protocol for Medical Devices in the
Workshop on the Packaging of Contraceptive devices held on May 17-18, 1999 at Indian Institute of Technology,
New Delhi
 Presented a paper on the Evaluation of Medical Devices in the International Seminar on Plastic Testing
2001,conducted by CIPET in Chennai
 Conducted two day seminar on GLP for the analysts and Technical assistants of the Drug Testing Laboratory of
Drug Control Department – Govt. of Kerala

9.  Presented a paper on “Introduction of Microbicides- key factors” in the Symposium on Microbicides in
development and their potential for prevention of STI’s and Pregnancy – conducted by the National Institute for
Research and Reproductive Health ,ICMR- India held on 21st and 22nd June 2004.
 Presented a paper on “CE marking of Medical Devices and the recent developments in global medical device
regulation scenario” at Biomedical and medical devices quality awareness program held on the 3rd September at
Sree Chitra Institute of Medical Sciences and Technology, Trivandrum.
TRAININGS ATTENDED:
 1990 - Plastic processing techniques- CIPET Madras
 1991 - GMP training at Buffallo-New York(21 days)
 1993 - Lead assessor course - Quality Management International
 1994 - Radiation Sterilization at Buffallo & New York(15 days)
 - Advanced Course in Spectroscopy –S.P. College –Pune
 2002 – Successfully completed Lead Assessor Course to conduct audit in ISO 9001- 2000 – BVQI – Nasik
 2003- 10 days training program on Training of Trainers conducted by Govt. of Singapore in Quality & Productivity
Improvement at Civil Services College Singapore.
 2003 – Lead Assessor course to conduct audit in ISO 14001- 1996
 2005 – Training in GHTF guidelines conducted by APEC and US Department of commerce in Bangkok from
13/6/05 to 17/6/05
OVERSEAS EXPOSURE :
a. United States: In 1991(21 days) and 1994(15 days) for training in related to Good Manufacturing
practices, Gamma Radiation Sterilisation.
b. Sweden: In 1994 at Apotekt Bolaget for evolving testing procedures for IUDs.
c. South Africa: In 2004 to attend the Technical Committee meeting of TC 157 of ISO.
d. Singapore: In 2003 to attend a training program on Quality and productivity at Civil Services College –
Singapore under Singapore cooperation program
e. Malaysia: In 2003 to attend the Technical committee meeting of ISO TC 157.
f. Thailand: In 2003 and 2005 to attend the Asian Harmonisation Working Party(AHWP) meeting
g. Taiwan : In 2004 to attend the AHWP meeting
h. China: In 2003 and 2005 for attending reproductive health expo in 2003 and to evaluate the
contraceptive products available in China to be adopted in the National Family Welfare program of India.
i. Geneva: In September 2006 to attend the IUD Technical Review Meeting of WHO
j. France: To finalise the tie up with Pasteur Institute – France for vaccine research in September 2006
k. USA: To finalise collaboration with CDC Atlanta, Emory Medical School and to attend the Technical
committee meeting at CDRH- Rockville- March 2007
l. Singapore: Attended World vaccine congress- June 2007

10. PERSONAL DETAILS
 Date of Birth: 27.07.1963
 Address: No 16, Site A, Kowdiar Gardens, Thiruvananthapuram, Kerala, State- India. Pin: 695 003
 Phone: Mob: +919582150686, Res: 91-471-2435650,
 E-mail:rasok@hotmail.com, rasokkumar@gmail.com