{"id":769,"date":"2025-07-19T20:40:13","date_gmt":"2025-07-19T20:40:13","guid":{"rendered":"https:\/\/mediwhale.stage.studio-jt.co.kr\/kr\/?post_type=openroles&p=769"},"modified":"2025-07-23T18:06:25","modified_gmt":"2025-07-23T09:06:25","slug":"raqa-specialist","status":"publish","type":"openroles","link":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/openroles\/raqa-specialist\/","title":{"rendered":"RA&QA \ub2f4\ub2f9\uc790"},"content":{"rendered":"\n

\ud68c\uc0ac \uc18c\uac1c:<\/h4>\n\n\n\n

\uba54\ub514\uc6e8\uc77c\uc740 \ub9dd\ub9c9 \ubc14\uc774\uc624\ub9c8\ucee4\ub97c \ud65c\uc6a9\ud558\uc5ec \uc2ec\ud608\uad00, \uc2e0\uc7a5, \ub300\uc0ac\uc131 \uc9c8\ud658 (CVRM) \uc704\ud5d8\uc744 \uc608\uce21\ud558\ub294 AI \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc5c5\uc785\ub2c8\ub2e4. \ub208\uc740 \ube44\uce68\uc2b5\uc801\uc73c\ub85c \uce68\uc2b5\uc801\uc778 \uc2dc\uc220 \uc5c6\uc774 \ud608\uad00\uc744 \uc9c1\uc811 \uad00\ucc30 \ud560 \uc218 \uc788\ub294 \uc720\uc77c\ud55c \uc778\uccb4 \uae30\uad00\uc774\uba70, \uc774\ub294 \uc2e0\uccb4 \uac74\uac15\uc5d0 \ub300\ud55c \uc911\uc694\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uba54\ub514\uc6e8\uc77c\uc740 \ubbf8\ub798\uc758 \uac74\uac15 \uc704\ud5d8\ub3c4\ub97c \uc9c4\ub2e8\ud558\ub294 \ub9dd\ub9c9 \uae30\ubc18 AI \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud558\ub294 \uae30\uc5c5\uc73c\ub85c \uad6d\ub0b4 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00\ub97c 2022\ub144 8\uc6d4 \ud68d\ub4dd\ud558\uc600\uace0 2023\ub144 6\uc6d4\ubd80\ud130 \uc758\ub8cc\uae30\uad00\uc5d0\uc11c \ube44\uae09\uc5ec \ucc98\ubc29\uc774 \uac00\ub2a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uba54\ub514\uc6e8\uc77c\uc758 \uaddc\uc81c \ub2f4\ub2f9\uc790\ub294 \uad6d\ub0b4 \ubc0f \uad6d\uc81c \uc758\ub8cc\uae30\uae30\uc758 \uaddc\uc81c \uc2b9\uc778 \ubc0f \uc9c0\uc18d\uc801\uc778 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ubcf4\uac74\ub2f9\uad6d\uacfc \ud611\ub825\ud558\uc5ec \uae30\uae30 \ub4f1\ub85d \ubc0f \uaddc\uc81c \uc804\ub7b5\uc744 \uc218\ub9bd\ud558\uace0 \uad00\ub9ac\ud569\ub2c8\ub2e4. \uc774 \uc5ed\ud560\uc740 \uc0c8\ub85c\uc6b4 \uc81c\ud488\uc758 \uc2dc\uc7a5 \ucd9c\uc2dc \ubc0f \uae30\uc874 \uc81c\ud488\uc758 \ud488\uc9c8 \ubcf4\uc99d\uc744 \uc704\ud55c \ud544\uc218\uc801\uc778 \uaddc\uc81c \ud504\ub85c\uc138\uc2a4\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc5ed\ud560:<\/strong><\/strong><\/h4>\n\n\n\n
    \n
  • \uc2e0\uaddc \uc81c\ud488 \uac1c\ubc1c \ubc0f \uae30\uc874 \uc81c\ud488 \ubcc0\uacbd\uc5d0 \ub300\ud55c \uaddc\uc81c \uc804\ub7b5 \uc218\ub9bd \ubc0f \uc2e4\ud589<\/li>\n\n\n\n
  • \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \ubc0f \ub4f1\ub85d \uc5c5\ubb34 \uc218\ud589<\/li>\n\n\n\n
  • \uad6d\ub0b4\/\uc678 \ucee8\uc124\ud134\ud2b8 \uad00\ub9ac \ubc0f \ud611\uc5c5<\/li>\n\n\n\n
  • \uc81c\ud488 \uac1c\ubc1c, \uc5f0\uad6c \uc870\uc9c1 \ub4f1 \ub2e4\uc591\ud55c \ub0b4\ubd80 \uc774\ud574\uad00\uacc4\uc790\uc640\uc758 \ud611\uc5c5 \ubc0f \uc870\uc728<\/li>\n\n\n\n
  • \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c(QMS)\uc758 \uac1c\ubc1c\ubd80\ud130 \uc2e4\ud589, \uc720\uc9c0 \ubc0f \uac1c\uc120\uae4c\uc9c0 \uc804 \uacfc\uc815 \uad00\ub9ac<\/li>\n\n\n\n
  • \ud504\ub85c\uc138\uc2a4 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \ub0b4\ubd80 \ud488\uc9c8 \uc2ec\uc0ac\uc758 \uacc4\ud68d \uc218\ub9bd\ubd80\ud130 \uc2e4\ud589, \uacb0\uacfc \uacf5\uc720\uae4c\uc9c0 \uc804 \uacfc\uc815\uc744 \uc8fc\ub3c4\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n
  • \uc678\ubd80 \ud488\uc9c8 \uc2ec\uc0ac\uc5d0 \ub300\ud55c \uc804\ubc18\uc801\uc778 \ub300\uc751\uc744 \ucc45\uc784\uc9d1\ub2c8\ub2e4.<\/li>\n\n\n\n
  • \uc2dc\ud310 \ud6c4 \uac10\uc2dc (PMS), \uc704\ud5d8\uad00\ub9ac, \uc2dc\uc815\u00b7\uc608\ubc29 \uc870\uce58 (CAPA) \uc2dc\uc2a4\ud15c\uc744 \uc6b4\uc601\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n
  • \uad6d\ub0b4\uc678 \uaddc\uc81c \ud658\uacbd \ubcc0\ud654\ub97c \uc9c0\uc18d\uc801\uc73c\ub85c \ubaa8\ub2c8\ud130\ub9c1<\/li>\n<\/ul>\n\n\n\n

    \uc790\uaca9\uc694\uac74:<\/strong><\/strong><\/h4>\n\n\n\n
      \n
    • \uc57d\ud559, \uc0dd\uba85\uacfc\ud559, \uacf5\ud559, \ud639\uc740 \ucef4\ud4e8\ud130 \uacf5\ud559 \uad00\ub828\uacc4\uc5f4 \ud559\uc0ac \uc774\uc0c1<\/li>\n\n\n\n
    • \uad6d\ub0b4 \ubc0f \uad6d\uc81c \uc758\ub8cc\uae30\uae30 \ubc0f \uc81c\uc57d \ubd84\uc57c \uc778\ud5c8\uac00 \uc5c5\ubb34 \uacbd\ud5d8 3\ub144 \uc774\uc0c1<\/li>\n\n\n\n
    • KFDA, EU MDR, ISO 13485 \ubc0f \uae30\ud0c0 \uad6d\uac00 \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uc5d0 \ub300\ud55c \uae4a\uc740 \uc774\ud574<\/li>\n<\/ul>\n\n\n\n

      \uc6b0\ub300\uc0ac\ud56d:<\/strong><\/strong><\/h4>\n\n\n\n
        \n
      • \uaddc\uc81c \uc804\ub7b5 \uc218\ub9bd \ubc0f \ud504\ub85c\uc81d\ud2b8 \uad00\ub9ac \uacbd\ud5d8 \uc6b0\ub300<\/li>\n\n\n\n
      • MDR, FDA \uaddc\uc81c \uacbd\ud5d8 \uc6b0\ub300<\/li>\n<\/ul>\n\n\n\n

        \uc5ed\ub7c9:<\/strong><\/strong><\/h4>\n\n\n\n
          \n
        • \uc5ed\ud560\uc744 \uc81c\ud55c\ud558\uc9c0 \uc54a\uace0 \uc801\uadf9\uc801\uc73c\ub85c, \uc8fc\ub3c4\uc801\uc73c\ub85c \uc77c\ud558\ub294 \ud0dc\ub3c4<\/li>\n\n\n\n
        • \uc0c1\ub300\ubc29\uc744 \uc124\ub4dd\ud558\uace0 \uc774\ud574\uc2dc\ud0a4\ub294 \ucee4\ubba4\ub2c8\ucf00\uc774\uc158<\/li>\n\n\n\n
        • \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\uc5d0 \ub300\ud55c \uc774\ud574<\/li>\n\n\n\n
        • \ube44\uc988\ub2c8\uc2a4 \ub9c8\uc778\ub4dc\uc14b\uc5d0 \uae30\ubc18\ud55c \uc804\ub7b5\uc801 \uc0ac\uace0<\/li>\n\n\n\n
        • \uad6d\/\uc601\ubb38 \ubb38\uc11c \uc791\uc131 \ubc0f \ub3c5\ud574<\/li>\n\n\n\n
        • \uc81c\ud488\uc758 \uc804 \uc0dd\uc560\uc8fc\uae30\ub97c \uace0\ub824\ud55c \uaddc\uc81c \uc804\ub7b5 \uc218\ub9bd<\/li>\n\n\n\n
        • \ub6f0\uc5b4\ub09c \ubd84\uc11d\ub825 \ubc0f \ubb38\uc81c \ud574\uacb0<\/li>\n\n\n\n
        • \uba85\ud655\ud55c \uc758\uc0ac\uc18c\ud1b5 \ubc0f \ud611\uc5c5<\/li>\n\n\n\n
        • \uacfc\ud559\uc801 \uc0ac\uace0\uc5d0 \uae30\ubc18\ud55c \uadfc\uac70 \uc911\uc2ec \ub17c\ub9ac \uad6c\ucd95<\/li>\n\n\n\n
        • \ube60\ub974\uac8c \ubcc0\ud654\ud558\ub294 \ud658\uacbd\uc5d0\uc11c \uc6b0\uc120\uc21c\uc704 \uc870\uc815 \ubc0f \ud6a8\uacfc\uc801\uc73c\ub85c \ub2e4\uc911 \uc791\uc5c5\uc744 \uad00\ub9ac<\/li>\n\n\n\n
        • \uc138\ubd80 \uc0ac\ud56d\uc744 \ucca0\uc800\ud788 \uac80\ud1a0\ud558\uace0 \ubb38\uc11c\ud654<\/li>\n\n\n\n
        • \ucef4\ud50c\ub77c\uc774\uc5b8\uc2a4 \ubc0f \uc724\ub9ac \uc758\uc2dd<\/li>\n<\/ul>\n\n\n\n

          \uadfc\ubb34\ud658\uacbd:<\/strong><\/h4>\n\n\n\n
            \n
          • \uc720\uc5f0\ud55c \uadfc\ubb34\uc870\uac74 (\uc2dc\ucc28\ucd9c\ud1f4\uadfc\uc81c \ubc0f \uc8fc 2\ud68c \uc7ac\ud0dd\uadfc\ubb34 \uac00\ub2a5) <\/li>\n\n\n\n
          • \uc810\uc2ec \uc2dd\ub300 (\uadfc\ubb34\uc7a5\uc18c \ubd88\ubb38), \ucee4\ud53c, \uc74c\ub8cc, \uac04\uc2dd \uc9c0\uc6d0<\/li>\n\n\n\n
          • \uc885\ud569\uac74\uac15\uac80\uc9c4 \uc5f01\ud68c \uc81c\uacf5<\/li>\n\n\n\n
          • \ubc95\uc815\uc5f0\ucc28\ud734\uac00 \uc678 \ubc31\uc2e0 \ud734\uac00, \uc0dd\uc77c \ud734\uac00, \uacbd\uc870 \ud734\uac00 \ub4f1 \ucd94\uac00 \uc81c\uacf5<\/li>\n\n\n\n
          • \uc5c5\ubb34 \uad00\ub828 \ub3c4\uc11c, \uc9c1\ubb34 \uad00\ub828 \uac15\uc758 \uc9c0\uc6d0<\/li>\n<\/ul>\n\n\n\n

            \ucc44\uc6a9 \uc808\ucc28:<\/strong><\/h4>\n\n\n\n
              \n
            • \uc11c\ub958 – 1\ucc28 \uc778\ud130\ubdf0 – 2\ucc28 \uc778\ud130\ubdf0 – \ucd5c\uc885\ud569\uaca9\n
                \n
              • \uc9c1\ubb34\uc5d0 \ub530\ub77c \uacfc\uc81c\uac00 \uc8fc\uc5b4\uc9c8 \uc218 \uc788\uc73c\uba70, \uba74\uc811 \uc808\ucc28\uac00 \ubcc0\uacbd\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • \ucc44\uc6a9\uc11c\ub958: \uc790\uc720 \uc591\uc2dd (\uc774\ub825\uc11c \ud3ec\ud568)\n
                  \n
                • \uba54\ub514\uc6e8\uc77c \uc9c0\uc6d0 \ub3d9\uae30, \uc9c1\ubb34 \uc9c0\uc6d0 \ub3d9\uae30, \uc9c1\ubb34 \uac15\uc810 \ub4f1\uc744 \uc5b4\ud544\ud574 \uc8fc\uc2dc\uae30 \ubc14\ub78d\ub2c8\ub2e4.<\/li>\n\n\n\n
                • \uad6d\ubb38, \uc601\ubb38 \uc774\ub825\uc11c \uac01 1\ubd80 \uc81c\ucd9c\ud574\uc8fc\uc2dc\uae30 \ubc14\ub78d\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n
                • \uc778\ud130\ubdf0: \uba74\uc811\uc740 \uac01 30\ubd84 ~ 50\ubd84 \ub0b4\uc678 \uc18c\uc694 \uc608\uc815 \uba54\ub514\uc6e8\uc77c\uc744 \uc9e7\uac8c \uc18c\uac1c\ud558\ub294 \uc2dc\uac04\uc744 \uac00\uc9c0\uba70, \uc11c\ub958\uc804\ud615 \ud569\uaca9\uc790 \ubd84\ub4e4\uc744 \ub300\uc0c1\uc73c\ub85c \uc9c1\ubb34\uc640 \ud68c\uc0ac \uc801\ud569\uc131\uc744 \uc54c\uc544\ubcf4\ub294 \uc2dc\uac04\uc744 \uac00\uc9c8 \uc608\uc815\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n","protected":false},"template":"","openroles_categories":[62],"class_list":["post-769","openroles","type-openroles","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/openroles\/769","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/openroles"}],"about":[{"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/types\/openroles"}],"version-history":[{"count":4,"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/openroles\/769\/revisions"}],"predecessor-version":[{"id":1396,"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/openroles\/769\/revisions\/1396"}],"wp:attachment":[{"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/media?parent=769"}],"wp:term":[{"taxonomy":"openroles_categories","embeddable":true,"href":"https:\/\/mediwhale.stage.studio-jt.co.kr\/ko\/wp-json\/wp\/v2\/openroles_categories?post=769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}