Please click here to apply through our internal career site Find Jobs - Elekta.
We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
新製品の上市に向けた規制当局の承認等（承認・認証・届出）取得および既承認等製品が薬機法に適合した状態で維持されるよう管理する業務。業務の内容には以下を含むがこの限りではない。
Responsibility includes, but not limited to, obtaining regulatory clearance to launce new products and maintaining regulatorily cleared products within legal in accordance with the Japanese Pharmaceuticals and Medical device law.
Ø 新製品の上市に向けた規制当局による承認等の取得、または既承認等製品が薬機法に適合した状態で維持されるよう管理するために必要な業務（一部変更承認申請等）に直接従事する。
Directly works on necessary tasks to obtain regulatory approvals/clearances/accreditations for new products for launch or to maintain regulatory cleared products within legal according to the Japanese Pharmaceuticals and Medical device law.
Ø 当社が本邦での上市を決定した製品（医療機器）について、薬機法で規定する承認等の取得に必要な情報を収集し、承認等取得のための戦略を策定し、申請書類（STED および関連技術文書を含む）を作成し、医薬品医療機器総合機構（PMDA）およびその他の関連当局と折衝を行う業務を担う。また、必要に応じて、保険償還に関する申請やその他の当局への届出等を行う。
To gather information necessary for obtaining regulatory clearance of products which EKK decides to launch in Japan, setting strategy to get regulatory clearance, prepare submission dossier (including STED and supporting technical documents), perform regulatory formalities, and negotiate with PMDA and other authorities. Submission of insurance re-imbursement request and other notification to the authority as necessary.
Ø 薬機法関連通知等に基づく各種管理業務（販促文書確認、注意事項等情報（添付文書）のアップデート他）
Other regulatory formalities according to the instruction from MHLW, PMDA or industrial group (including review of marketing/sales materials, and revision of package inserts, etc.)
Ø 海外製造元との薬事に関するコミュニケーション、折衝、調整
Negociation, communication and information sharing with product supply center (manufacturers) overseas.
Ø 社内各部門との薬機法許認可取得に関する各種コミュニケーション、調整
Negociation, communication and information sharing with other department within EKK.
Ø その他
Other tasks related to above activities.