Jobs list of Medical Device & Regulatory Affairs (RA)
-
NEWJob number: JN -072025-190865 Posted: 2025-08-15
Regulatory Affairs Specialist
高度医療機器の薬事ポジション6 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a world leading medical device manufacturer.
- Responsibilities
- 業務内容：
経カテーテル弁留置用デバイスやステントグラフトなどを中心とした製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、海外製造元および関連部署と協力して、薬事承認および保険に関する申請戦略を立案する。
薬事申請戦略および作業計画に基づき、海外製造元および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成し、審査当局に提出し、承認取得する。
製品の変更情報に対する評価、対応
関係部署と連携して添付文書作成、保険適用業務を行う。
米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。
国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。
販促物（カタログ等）の内容確認
その他薬事関連業務の進行
Go Ozawa
Industrial & Life Science -
NEWJob number: JN -072025-191705 Posted: 2025-08-15
海外薬事業務
欧州、米国の医療機器の薬事申請のご経験をお持ちの方必見です！7 - 9.5 million yen Osaka Medical Device Regulatory Affairs (RA)
- Company overview
- We are a chemical manufacturer. We mainly manufacture chemical products, food products, medical products, and electronic materials. We aim to contribute to the sustainable development of society through the development of innovative technologies. In particular, we focus on the development of environmentally friendly products and the promotion of recycling technologies. With offices around the world, we are active in the global marketplace and have built trust by meeting the diverse needs of our customer
- Responsibilities
- 薬事承認/認証取得のための申請書作成および照会対応（第三者認証機関との打合せ、変更申請を含む）
設計、開発、臨床学術、製造、提携先等との協議および調整（試験計画を含む準備、照会回答等）
第三者認証機関による監査対応
法規制情報の収集および社内関係者への周知
Go Ozawa
Industrial & Life Science -
NEWJob number: JN -072025-191918 Posted: 2025-08-15
薬事業務
3年以上の医療機器QMS又はGVPに関する業務を含む薬機法等、医療機器法規制に関する業務経験のある方必見です5.24 - 8.6 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We provide tech solution products, inheriting numerous manufacturing equipment businesses and integrating trading and manufacturing functions to offer a wide range of products. Our business includes inheriting surface mount system business, LCD and hard disk-related manufacturing equipment business, and semiconductor post-process manufacturing equipment business, seamlessly integrating trading and manufacturing functions.
- Responsibilities
- 医療機器に関する品質マネジメントシステムの維持管理、薬機法等国内外の医療機器法規制への遵法体制の維持に係る各種薬事業務。日立ハイテクで製造販売する医療機器に関し、各国医療機器規制に対する法令順守を実現するため、設計、品質保証部門等と連携し業務を行います。製品製造販売届出※1はじめ、製品の製造販売等に必要な各種届出や製造販売業許可、製造業登録等の申請・変更・更新業務など薬事業務全般を担当いただきます。加えて、医療機器品質マネジメントシステムの維持管理のため、手順書の整備、各種社内教育の実施、認証機関との窓口業務等もご担当いただきます。また、市販後安全管理業務のご経験がある方は、当該業務のご担当も可能です。
加えて、社内関係部署等から寄せられる薬事法令に関する相談対応もコア業務の一つとなります。
※1：当部署で担当する製品の製造販売申請は、主にクラスⅠ医療機器となります。
Risa Harada
Industrial & Life Science -
Job number: JN -082024-173752 Posted: 2025-07-08
Senior specialist/manager, Regulatory Affairs
勤務地は東京or大阪（リモートワーク有）7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our Client is a global medtech company that provides medical devices, lab equipment, and diagnostic products in their focus areas such as medication management, infection prevention, diagnostics, and healthcare delivery solutions.
- Responsibilities
- Job Description Summary:
A global medtech company is looking for a highly motivated individual to join our team as Regulatory Affairs Specialist/Manager in the Pharmaceuticals Division. The successful candidate will be responsible for obtaining regulatory approval of new products and maintaining existing licenses in line with local regulations, while ensuring compliance with all relevant laws and regulations. This role will involve collaborating closely with cross-functional teams to ensure timely and effective product launches, as well as ongoing support for marketed products. The position requires excellent organizational skills, attention to detail, and strong communication abilities.
Job Responsibilities:
Lead and coordinate regulatory activities related to drug registration, including preparation of required documents and submission to authorities.
Collaborate with internal stakeholders such as R&D, Manufacturing, Quality Assurance, Marketing and Sales to gather information necessary for regulatory submissions.
Ensure compliance with all relevant regulations and guidelines, including GCP standards.
Stay updated on changes in regulatory requirements and guidance documents, and implement appropriate measures to address any impacts on current or future registrations.
Maintain accurate records of all regulatory documentation, including filings, correspondence, and inspection reports.
Support preparation and review of promotional materials to ensure compliance with regulatory requirements.
Coordinate interactions with regulators during site visits or meetings, providing clear and concise explanations of technical aspects related to product registration.
Work closely with external consultants and experts to facilitate smooth progress of registration process.
Provide regular updates to management regarding status of registration activities.
━━━━━━━━━━━━━━━#poweredjob3
Risa Harada
Industrial & Life Science -
Job number: JN -122024-180834 Posted: 2025-07-08
内視鏡開発のプロダクトマネージャー（Regulatory Affairs）
挑戦できる文化あり／課題解決に役立てる環境5 - 8 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
- Responsibilities
- 本部署では、新製品開発における製品登録および既存製品に関する規制対応Regulatory Affairsの視点から担当します。グローバルコミュニケーションが必要で、R&D、QA、工場との連携しながら業務を遂行いただきます。
業務内容：
製品開発の初期段階から、Regulatory Affairsの視点で申請書類を作成サポート
海外での製品登録およびその他の地域での登録サポート
既存製品の市場維持のためのRegulatory Affairsサポート
海外拠点とのコミュニケーション
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-25913 Posted: 2025-06-16
Regulatory Affairs Specialist
Global pioneer in healthcare industry7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We specialize in the development and marketing of medical devices. We provide advanced medical devices used primarily in the fields of cardiovascular, urology, and gastroenterology to assist in the treatment and diagnosis of patients. With an emphasis on innovative technology and research and development, we are continuously introducing products to the market that meet the needs of the medical field. Our product lineup includes catheters, stents, and endoscopic devices that boast high quality and safety. Through collaboration with medical experts, we also aim to promote effective therapies and improve medical technology. With a mission to improve the quality of life of patients, we leverage our global network to provide superior solutions to medical institutions around the world.
- Responsibilities
- Main responsibilities:
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
Provide management team with regular updates on product registration and new regulations from government body.
Provides input on regulatory- related issues associated with compliance and achieving the business plans.
Prioritize and plan on product registration for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
Provide the management team with regular updates on product registration.
Ensure product registrations are reviewed and renewed as required.
Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
Supports tender operations by timely supply of accurate regulatory documents.
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
Serves as regulatory consultant to marketing team and government regulatory agencies.
Complete the mandatory Quality training subject to the defined timeline.
And ensure compliance with internal Quality system and policy.
Go Ozawa
Industrial & Life Science -
Job number: JN -052025-188968 Posted: 2025-06-16
Senior Safety Control Specialist
Advance surgery, empower teams, and change lives7.6416 - 11 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is the global technology leader in minimally invasive surgery.
- Responsibilities
- Main responsibilities:
Preparation and implementation of GVP in compliance with Japanese PAL.
Collection and first reviewer of local and overseas post-marketing safety information.
Review / approve the evaluation of local and overseas post-marketing safety information.
Manage an outsourced contractor daily work.
Complaint handling management for filings and prepare the customer letter.
Communication with head office on complaint cases for preparation of customer letter.
Support quality management activity and work with QA team to maintain the appropriate quality
management system.
Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality
management in a timely manner.
Continuous improvement and management of the safety/quality assurance process in accordance with Product Development Process.
Work directly with regulatory agencies on safety/quality issues and submissions.
Documentation of Package Insert and PMDA web maintenance of Package Insert
Elaine Montes
Industrial & Life Science -
Job number: JN -062025-189318 Posted: 2025-06-16
【愛知県小牧市】医療機器品質管理・薬事申請＜スペシャリスト＞
医療機器等の品質管理経験者必見です!5 - 5.94 million yen Aichi Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is an optical component manufacturer.
- Responsibilities
- 本ポジションでは、各国医療機器規制対応の為の薬事管理業務全般をお任せします。ISO 13485に基づくQMS維持管理、EU MDR移行申請、US FDA 510(k)申請及び国内製品認証申請の対応などもご担当いただきます。
業務詳細:
各国医療機器規制に則った製品認証の取得および維持管理業務
顧客からの品質問題に関する問い合わせ対応（リコール関連手続き含む）
品質向上に向けた製造工程での課題の抽出、解決方法の検討と運用など
Go Ozawa
Industrial & Life Science -
Job number: JN -052025-188151 Posted: 2025-05-16
医療機器の薬事
医療機器薬事業務の経験をお持ちの方必見です6 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
- Responsibilities
- 同社サージェリー事業部が扱っている外科領域製品の薬事申請を行っていただきます。※スキル・ご経験に応じて、他事業部へアサインする可能性あり。主な業務内容:
担当製品の薬事戦略立案から、薬事申請（承認申請、認証申請、届出）・承認等の取得
変更管理に至る薬事対応業務全般(行政相談を含む)の推進および実施
社内規定に基づく広告審査業務および関連するステークホルダーからの問い合わせ対応
社内関係部門との調整や、コンプライアンスに関わる業務の遂行
社内の組織的活動への貢献
薬事部門内外のイベントへの参加および貢献
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -122024-181689 Posted: 2025-05-07
薬事スペシャリスト（薬事品質保証業務）
薬事申請での実務経験者必見です!7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- 欧州発の医療機器メーカーです。
- Responsibilities
- 医療機器の薬事申請業務全般 （対象となる医療機器のクラス：1～4）
製造販売承認・認証申請等業務
-薬事申請文書の作成、申請 -資料取集（海外製造元からのデータ収集・管理、各種調整折衝 ）-PMDA・認証機関との折衝（PMDA相談、照会対応を含む） -申請に必要な規格試験等の実施 保険収載業務（保険適用希望書作成等）
業態の許可管理、更新申請
添付文書の作成並びに維持管理
-販促物（カタログ等）の内容確認 -安全管理業務（GVP）のサポート -その他
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-19149 Posted: 2025-04-25
【東京】再生医療機器 / 薬事・安全管理
【東京】再生医療機器の薬事6 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is selling, importing and exporting pharmaceuticals and other products.
- Responsibilities
- 医療機器に関する法規制対応業務のうち、以下：各国 製品登録関連業務（日本 薬事承認・認証等取得および維持管理。米国 510(k)・PMA 等海外の承認・認証取得および維持管理。当局相談 等）
各国 安全管理業務（治験等市販前～市販後を通して製品ライフサイクル全般）
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-22566 Posted: 2025-04-25
薬事申請業務
日系大手医療機器メーカー 薬事申請業務6 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
- Responsibilities
- 医療機器の薬事スペシャリスト画像診断装置の薬事申請診断支援装置(CAD)、診断用ワークステーション、内視鏡、X線診断装置、等 主にクラス２の医療機器
薬事戦略立案から、申請までの推進及び実施(承認申請、認証申請)米国FDA、欧州MDR対応等、世界展開する為の各国海外申請を含む
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-149456 Posted: 2025-04-25
Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト
Class IV RAにご興味ある方が対象です7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a global medical devices and pharmaceutical company providing healthcare-related products. We offer a wide range of products including pharmaceuticals, medical devices, and consumer goods to support healthy living. Particularly, through investments in medical technology and research and development, we provide advanced medical solutions, enhancing the quality and efficiency of healthcare. Additionally, we contribute to raising awareness of health in society through education and outreach activities, aiming for a better future.
- Responsibilities
- 日本国内で心臓アブレーション治療や脳血管治療関連の製品を展開しています。その薬事担当としてクラスIV機器の新製品導入・適応拡大といったチャレンジングな薬事申請及び既存製品の維持活動を主たる業務とするポジションです。
業務内容：
海外製造元、ビジネス部門、臨床部門、品質管理部門等と協業
PMDA、MHLWとの交渉を成功に導くことで、承認取得から保険適用、製品発売、市販後の社内外のプロセスを完遂していただきます。
CSS RA Headにレポートします
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-4978 Posted: 2025-04-25
RA Manager
People Management経験不問です！7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are an innovative solution provider specializing in the health and wellness sector in Japan. The company develops medical devices and healthcare solutions based on advanced technology and in-depth understanding. This helps improve the quality of healthcare and optimize patient care, thereby contributing to better health. The company also pursues sustainable innovation and contributes to improving health and wellbeing in society. We are committed to providing comprehensive healthcare solutions through a variety of partnerships and collaborations.
- Responsibilities
- 製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応）
承認／認証の維持管理業務（変更管理、定期更新）
QMS適合性調査申請
保険収載業務（保険適用希望書作成等）
Shotaro Tsubaki
Industrial & Life Science -
Job number: JN -072024-150696 Posted: 2025-04-01
Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト
大手医療機器メーカーの薬事ポジション7 - 11 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a world leading medical device manufacturer.
- Responsibilities
- 必須要件：
製造販売承認取得及び既存製品の維持管理業務
製品の特性やニーズに沿った承認申請戦略の立案
申請戦略及び製造元の原資料に基づく承認申請書の作成
行政当局からの照会に対する回答、社内部署や製造元との連携
法や通知に対する日常的な知識習得及び理解
添付文書、QMS申請、保険適用希望書の作成
販売促進資料の法的要求に関わる確認
製品の変更管理に関する判断
職務経験によっては在宅勤務可（応相談）
Go Ozawa
Industrial & Life Science -
Job number: JN -122024-181552 Posted: 2025-02-14
CMC Manager / CMC Specialist
ワークライフバランスを考慮した働き方の実現6 - 12 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a provider of dental products and related services. We have developed a broad product lineup in the field of dentistry to meet the needs of dentists and dental technicians. In particular, we provide diagnostic and treatment instruments and materials necessary for dental treatment, as well as products utilizing digital technology, which are highly valued for their high quality and reliability. We are also actively involved in the latest trends and innovations in the dental industry to help improve patient outcomes and advance dental care. We are committed to strengthening our partnerships with the local community and contributing to better health through education and community activities.
- Responsibilities
- 業務内容：
歯科用医薬品の薬事申請業務
製品の変更管理、影響などの評価を行い、関連部門に報告する。内容により薬事対応も行う。
製造委託先及び外国製造所の管理業務
医薬品医療機器等法の要求事項を理解し、当社の品質システム文書への展開を行う。
関連部署と連携し、品質管理体制及び安全管理体制を現場に浸透させる。
主なコミュニケーション先製造委託先の品質保証、製造部門担当者
当社品質保証部門、製造部門、マーケティング、サービス部門担当者
Risa Harada
Industrial & Life Science -
Job number: JN -072024-168803 Posted: 2024-09-25
【大阪】薬事申請・事業開発
薬事申請経験者必見です!5 - 9 million yen Osaka Medical Device Regulatory Affairs (RA)
- Company overview
- Our client specialize in the development and sale of comprehensive functional materials, including optical films for crystal use. Leveraging polymer technology, we expand our business in various fields, guided by our "Global Niche Top" strategy. This strategy fosters a virtuous cycle, generating high-value-added products, supporting substantial research and development expenditures, and fostering innovative new technologies. We have a culture that encourages challenges and innovation, with no distinction between new graduates and experienced hires.
- Responsibilities
- 能動医療機器、プログラム医療機器の認証申請プロセスの管理と実行
医療機器の薬事戦略の立案と実行、規制当局との折衝
国内外の医療機器関連法規制の最新動向の追跡と分析
製品開発チームと協力し、規制要件を満たす製品設計の支援
【入社後まずお任せしたい業務】
認証申請業務
薬事、規制要件の調査、薬事戦略、保険戦略の立案
医療機器の製造販売業に関するQMS、GVP業務
医療機器の開発支援
Shotaro Tsubaki
Industrial & Life Science
1