{"id":3221619,"url":"https://alion.io/job/zeiss-supesharisuto-","title":"薬事スペシャリスト/医療機器（薬事臨床開発部）","company":{"id":5290,"name":"Zeiss","domain":"zeiss.com","url":"https://alion.io/company/zeiss","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":177,"ghost_share":0,"stale_share":0.847,"repost_share":0.006,"time_to_fill_p50_days":36,"computed_at":"2026-10-27T05:46:45Z"}},"role":"HR","role_family":"HR","seniority":null,"employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-27T10:46:25Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"業務内容\n薬事業務全般（クラスI～III）\n・日本における医療機器の承認申請等資料の作成及び管理\n・新製品導入戦略や薬事戦略をPMDA/認証機関と協議・交渉しながら策定\n・社内および/または社外のリソースを活用して、スケジュール内および予算内で承認を取得\n・業許可と承認等の維持 1. 日本における申請等資料の作成\n・医薬品医療機器等法や関連法規を理解する\n・外国製造所より製品情報、開発文書を収集\n・薬事戦略を策定（PMDA との協議・交渉も含む）\n・社内および外国製造所と連携し、申請等資料を作成 2. 規制当局に提出した申請等資料の審査／調査対応\n・規制当局への申請等資料の提出\n・社内および外国製造所と連携し、提出書類に関する照会や調査に対応\n・期限内、予算内で承認を得る 3. 業許可と承認等の維持 4. 薬事承認後のサポート\n・品質・安全性部門との連携\n・社外向け資材のレビュー（例：マーケティングブローシャ）\n・変更管理への対応\n・保険適用申請\n必須条件\n- クラスII以上の医療機器の薬事業務経験が3年以上。 \n- 医療機器の承認等申請に関する実務経験\n- 医薬品医療機器等法の知識とコンプライアンス意識\n- PMDA相談の実務経験\n- 英語スキル（読み、書き、会話（会議で発言できる程度））\n- 論理的思考と論理的文章\n- 積極的なコミュニケーションスキル\n- グローバルな考え方\n-リスクマネジメント活動\n歓迎条件\n- 非能動医療機器の承認等申請に関する実務経験\n- クラスIIIの承認等申請に関する実務経験\n- 品質関連業務における実務経験\n- 眼科に関する知識\n- ISO 13485:2016 内部監査員\n- クラスII以上の非能動医療機器の薬事業務経験が3年以上。\nYour ZEISS Recruiting Team:\nAmi Takeno （竹野 碧海）, Hiroko Okuda （奥田 裕子 - オクダ ヒロコ）, Maho Hatabayashi （畑林 真帆 - ハタバヤシ マホ）","description_format":"text","description_chars":862,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Japan","iso":"JP","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Eyewear","Medical Imaging Systems","Semiconductor Equipment"],"lifecycle":[{"event":"open","at":"2026-10-25T03:34:21Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":36,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/zeiss-supesharisuto-","json_url":"https://alion.io/job/zeiss-supesharisuto-.json","meta":{"generated_at":"2026-10-27T14:14:36Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":2668,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5290},"rest":"https://alion.io/mcp/rest/get_company?id=5290"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzeiss-supesharisuto-"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fzeiss-supesharisuto-"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fzeiss-supesharisuto-"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/zeiss-supesharisuto-\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzeiss-supesharisuto-"}]}