Tokyo (株)クラレ ¥7,000,000 - ¥9,400,000
【仕事内容】

【職務内容】

医療機器規制を理解した品質マネジメントシステムの専門家として、当社事業の品質保証、法規制対応を推進する役割を担っていただきます。

【お任せしたい業務】

入社後、医療機器規制への対応では、最新の医療機器規制に基づく品質マネジメントシステムの運営管理として、規制情報の分析、規定、基準類の作成・改訂、内部監査、認証機関監査の対応等幅広く担当いただきます。

【キャリアパスイメージ】

3年後のイメージ

各国の規制に基づく社内規定、基準類について自律的に作成・改訂が可能となり、品質システムの運用における、関係部署への指導ができるようになっていただきたいと考えています。

各部署の役割、責任の理解に基づく連携、協働をスムースに行えることを期待します。

5年後のイメージ

医療機器規制への対応を行う、後進者を束ねる組織のリーダーとして活動していただき、その時代の法規制環境や事業ニーズの理解に基づく課題を自ら立ち上げ、プロジェクトを推進できる人材になっていただきたいと考えています。

なお、事業の内容から、海外における子会社・代理店、業務委託先や規制当局...

【求める人材】

・語学 各国代理店、各国当局との英語によるコミュニケーションが可能であること(目安 TOEICスコア600以上)

・職務経験 各国医療機器、医薬部外品、医薬品関連、化粧品の規制に基づく品質保証業務の実務経験、または製品の開発経験(少なくとも2~3年)

・知識 化学

【給与】

700万円~940万円

■キャリア・能力を考慮の上、当社規定により処遇

【勤務地】

東京都

【勤務時間】

09:00~17:45

【雇用・契約形態】

【待遇・福利厚生】

【保険】健康保険、厚生年金保険、雇用保険、労災保険

【教育制度など】DX人材育成プログラム、グローバル人材育成プログラム(英語力向上支援策、短期駐在員)通勤手当、住宅手当、寮社宅(独身寮(個室))、単身赴任手当、勤務手当(東京勤務に対して)

【その他、福利厚生】退職金制度、退職一時金、確定給付企業年金、企業型確定拠出年金、持株会、福祉会、財形貯蓄、契約リゾート・スポーツ施設

【休日・休暇】

完全週休2日制(休日は土日祝日)、年間有給休暇15日~20日(下限日数は、入社半年経過後の付与日数となります)、年末年始休暇、年次有給休暇(初年度初日から15日/最大20日付与※入社月により4~15日)、慶弔休暇、裁判員などの公務休暇 時効年休の積立休暇(私傷病・ボランティア用途等)他
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