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Applications are invited for post of Regulatory Consultant at ICMR


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Applications are invited for post of Regulatory Consultant at ICMR

Indian Council of Medical Research (ICMR) is an Autonomous Organization, under the Department of Health Research, Ministry of Health & Family Welfare, Govt, of India. ICMR is dealing with biomedical/ health research in various areas, in collaboration with National/ International agencies, through its Headquarters at New Delhi and 27 Institutes/ Centres and a large number of field stations, situated across the country.

Post : Consultant (Regulatory) (Non-Medical)

ICMR intends to engage following Non-Institutional Project Position, purely on temporary contract basis for its short-term research projects, at Medical Device and Diagnostic Mission Secretariat (MDMS) unit under the Development Division at ICMR Hqrs.

No of post : One
Essential Qualifications and Experience : Professionals having PhD or MD in relevant subjects with research and development experience and published papers.
Desirable Qualifications
• Experience of handling regulatory matters & having knowledge of ISO 9001, ISO 13485, Medical Device Rules-2017, ISO 14971, IEC 62304, internal audits, quality assurance, clinical evaluation/ performance evaluation, medical device design and development.
• Exposure of medical device post-marketing support system.
• Experience of handling data of clinical research studies.
• Ability to communicate regulatory requirements and strategies effectively.

Nature of Duties
• Research and interpret regulations, guidelines and precedents to support MDMS unit in developing strategies, framework and procedures that ensure regulatory compliance with Medical Device Regulations (MDR), 2017.
• Prepare regulatory submissions for Medical Device (s)/ IVD products, & prepare response to queries of regulatory authorities within specific timelines
• Facilitate innovators in drafting Technical Documentation (Appendix II & Appendix III of MDR, 2017) needed to demonstrate compliance with applicable standards.
• Interface with regulatory agencies for inquiries and issues.
• Analysing testing standards, provide appropriate regulatory requirements and drafting clinical study protocol.
• To organise regulatory advisory meetings for MedTech innovators and follow up on action points and Committee recommendations.

Consolidated Emoluments : Rs.1,00,000/- per month
Age Limit : 70 Years (Max.)
Tenure :  1 year or till completion of the project, whichever is earlier

Place of work : ICMR Hqrs, New Delhi

General Terms and conditions :
1. Number of positions may vary.
2. These positions are meant for temporary projects and co-terminus with the project.
3. Engagement of the above advertised Project Human Resource positions will depend upon availability of funds, functional requirements and approval of the competent authority. Therefore, we are not committed to fill up all the advertised Project Human Resource positions and the process is liable to be withdrawn / cancelled / modified at any time.
4. The rates of emoluments/stipend shown in this advertisement are project specific and may vary according to sanction of the funding agency of the Project.
5. Cut-off date for age limit will be as on the date of last date for submission of applications.
6. Age relaxation will be as per the guidelines of ICMR.
7. Reserved category candidates must produce their latest Caste Validity Certificate. OBC candidates must possess a latest valid non-creamy layer certificate. PWD candidates shall produce latest disability certificate issued by a Medical board of Government hospital with not less than 40% disability.
8. Qualification & experience should be in relevant discipline/field and from an Institution of repute. Experience should have been gained after acquiring the minimum essential qualification.
9. Mere fulfilling the essential qualification does not guarantee the selection.
10. Persons already in regular time scale service under any Government Department / Organizations are not eligible to apply.

11. No TA/DA will be paid to attend interview / personal discussion and candidates have to arrange transport/accommodation themselves.
12. ICMR reserves rights to consider or reject any application/candidature.
13. Submission of wrong or false information during the process of selection shall disqualify the candidature at any stage.
14. Project Human Resource cannot be permitted to register for Ph.D., due to time constraints.
15. Project Human Resource will normally be posted at the study site; however, they can be posted to any other sites in the interest of research work. They are liable to serve in any part of the country.
16. Project Human Resource shall not have any claim on a regular post in ICMR or in any of its Institutes/Centers or in any Department of Government of India and their project term with breaks or without breaks in any or multiple projects will not confer any right for further assignment or transfer to any other project or appointment/absorption/regularization of service in funding agency or in ICMR. Benefits of Provident Fund, Pension Scheme, Leave Travel Concession, Medical claim, Staff Quarters and other facilities applicable to the regular staff of ICMR etc. are not admissible to the project human resource. 17. Project Human Resource will normally be engaged initially for a period of one year or less, and continued further after annual review on the basis of their performance, depending upon the tenure of the project, availability of funds, functional requirements and approval of competent authority. The maximum term of any Project Human Resource in any or multiple projects, with breaks or without breaks shall be five years only. The concerned Project Investigator, Division Head and Head of the host Institute shall personally be responsible and accountable for the continuation / extension given if any without prior concurrence of the Director General, ICMR to any project human resource beyond five years either with or without breaks in any or multiple projects.
18. ICMR reserves the right to terminate the project human resource even during the agreed contract period or extended contract period without assigning any reason.
19. Leave shall be as per the ICMR’s policy for project human resource.
20. Candidate must submit his/her duly filled in application form in the prescribed format with a recent passport size colour photograph along with a detailed bio-data/ CV and all relevant documents; duly self-attested; in proof of his/her educational qualifications [all certificates and mark-sheets from 10th Std. onwards], working experience, age, caste and photo id [Aadhaar Card/Indian Passport/PAN Card/Driving License] etc., within the schedule date and time for submission of application, failing which his/her candidature will not be considered. Late/ Delayed/ Incomplete/ Unsigned applications will not be considered at all and no correspondence will be entertained in this regard.

21. ICMR reserves the right to cancel/modify the process at any time, at its discretion.
22. The decision of the DG, ICMR will be final and binding.
23. Canvassing in any form will be a disqualification.
24. Corrigendum/addendum/further information; if any; in respect of this advertisement, will be published on our website only. Hence, the candidates are advised to see the website of ICMR regularly for further updates related to this advertisement.

Deserving candidates may send their applications in the prescribed form, duly filled in all respects along with all required supporting documents and certificates, duly self-attested, on the email: within the schedule date and time for submission of applications, i.e. on or before 4th January, 2024 up to 17:00 hours (no other mode of application will be entertained).

Application Form

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