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Job Location | Pune |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Medical / Healthcare |
Functional Area | Legal Support Services |
EmploymentType | Full-time |
The key purpose of this position is to support the Compliance activity for Mobile surgery systems with all relevant mandatory international and national standards. relevant mandatory international and national standards. General Key Areas of Responsibility Work on the project deliverables related to Compliance release evidence Identification of relevant clauses from standards for (sub)system Secure the implementation and verification of all specified legal requirements. Support with respect to technical realization/ engineering of compliance of the (sub)system. Support the verification (testing, witnessing and reporting and approval) of all specified legal requirements. Be the intermediary between development and certifying/ regulatory agencies (UL/ CSA/ FDA/ KEMA etc). Support arrangements for and completion of submission to certifying agencies. Identification of relevant clauses from standards for (sub)system Secure the implementation and verification of all specified legal requirements. Support with respect to technical realization/ engineering of compliance of the (sub)system. Support the verification (testing, witnessing and reporting and approval) of all specified legal requirements. Be the intermediary between development and certifying/ regulatory agencies (UL/ CSA/ FDA/ KEMA etc). Support arrangements for and completion of submission to certifying agencies. Specific Key Areas of responsibility: Project Manager Bachelor degree (preferably in electronics or directly related area. Preferably 4 7 years of experience Know- how & Skills: Bachelor degree (preferably in electronics/ Mechanics or directly related area). knowledge of relevant regulations (UL, CSA, IEC, ISO, DHHS, MDD, CE, Pal, etc.). knowledge of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.). Knows how to participate in Reviews from compliance viewpoint. Knows how to write proper submission forms. Quality & Regulatory insight. Personality Characteristics: Be able to work in teams Communicative. Disciplined team worker. Takes personal ownership for own deliverables in terms of content, quality and time. Feels committed to agreed team deliverables. Bachelor degree (preferably in electronics/ Mechanics or directly related area). knowledge of relevant regulations (UL, CSA, IEC, ISO, DHHS, MDD, CE, Pal, etc.). knowledge of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.). Knows how to participate in Reviews from compliance viewpoint. Knows how to write proper submission forms. Quality & Regulatory insight. Personality Characteristics: Be able to work in teams Communicative. Disciplined team worker. Takes personal ownership for own deliverables in terms of content, quality and time. Feels committed to agreed team deliverables.,
Keyskills :
scannersreportingcsamobileiecprintersqualityreviewsemcsurgerygovernmentengineeringriskisoregulatory agenciesstatements of work sowrisk managementradiation safety