Jobs list of Medical Device & Regulatory Affairs (RA)

Regulatory Affairs Specialist

Global pioneer in healthcare industry

7 - 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.

【東京】薬事担当

医療機器薬事のご経験者必見です!

7 - 15 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We are a Japanese medical device manufacturer aiming to improve patients\' quality of life as a global medical company. We develop, manufacture, sell, and service medical devices for the treatment and measurement of severe cardiovascular diseases, particularly excelling in artificial heart valves and valvuloplasty products for valve disease treatment, as well as critical care products like hemodynamic monitoring systems. We emphasize environmental protection, social contribution, and corporate governance responsibilities, promoting sustainable initiatives. Additionally, we provide support information and educational tools for healthcare professionals worldwide.
Responsibilities: モニタリング製品や付随するディスポーザブル製品の薬事申請業務全般
ラベリング、添付文書、宣伝資料等の確認や承認
その他付随する業務

医療機器の薬事

パイプライン豊富・グローバルに活躍

6.7 - 8.5 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We are a leading ophthalmic care company. We focus on the development and marketing of products and services that support eye health, including contact lenses and ophthalmic surgical instruments for improving vision and eye care. With a focus on innovation, we aim to solve vision-related problems and improve the quality of life by providing high-quality, safe products. We are also committed to social action programs and sustainable business models.
Responsibilities: ■ミッション：同社の薬事担当として眼科領域に特化した医薬品、医薬部外品、医療機器を日本で販売するための厚生労働省からの許認可取得とその維持をお任せします。

■業務内容【変更の範囲：会社の定める業務】
具体的には下記のような業務が発生します。担当製品／プロジェクトに対して質の高い薬事サポートをタイムリーに提供する。
社内外のステークホルダーと密に連携し、最良の薬事戦略を調整する。
迅速な許認可取得のために明確、簡潔、かつ正確な文書を作成する。
日本の規制要件、社内ポリシーおよびプロセスを遵守する。

■ポジションの魅力科学の知識を活かして種々の医療機器（クラスⅠ～Ⅲ、能動・非能動、インプラント・非インプラント）への薬事対応を担当することで、幅広い薬事知識・経験が得られます（将来的に医薬品、医薬部外品の薬事対応に携わる可能性あり）。
豊富な製品及び開発パイプラインを有し、常に眼科領域の最先端を学ぶことができます（新製品：5-10品目／年、既存品変更対応：10-20品目／年）。
世界各国のカウンターパートと連携をとり仕事を進めるので、グローバルに活躍ができます。

■働き方週に１回リモートワークを取り入れて働いております。

【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 Kansai 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

Regulatory Affairs Specialist | 薬事スペシャリスト

Global pioneer in healthcare seeks seasoned RA specialist

7 - 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.
Ensure compliance with internal Quality system and policy.

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

医療機器の設計開発・薬事申請（臨床評価）

自社製品開発に不可欠な専門人材になれる機会

6 - 7.5 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We are a leading Japanese manufacturer and distributor of medical devices and related products. We have a particularly strong reputation in the field of medical devices, such as catheters and artificial heart-lung machines, and we are expanding our business widely both domestically and internationally. We are also expanding into the fields of pharmaceuticals and blood systems, providing comprehensive medical solutions. We focus on innovation and quality control, and develop our products with patient safety and healthcare professionals\' convenience in mind. We aim to contribute to the development of healthcare from a global perspective and are actively involved in the realization of a sustainable society.
Responsibilities: カテーテル領域で使用される機器の臨床評価におけるプランの立案、実施、解析およびレポート作成をご担当いただきます。開発製品設計チームや薬事、臨床開発、品質保証部門などの複数部門と協力しながら、主担当として一製品のレポート作成までをお任せします。
業務内容：
評価対象機器について、臨床・非臨床データの収集および解析を行い、その結果が安全性および性能に関する法的要求事項に対して適合できているかどうか評価
規制当局または認証機関へ報告
臨床評価（Clinical Evaluation）
市販後臨床フォローアップ評価（Post-market Clinical Follow-up Evaluation）
EU-MDRおよびNMPAなど、関連法規に係る情報収集
認証申請／更新または承認申請に係る報告書作成および照会対応

Head of RA/QA | 薬事・品質保証ディレクター

Ensure patient safety as RAQA mgr @ top radiotherapy company

13 - 16 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: Our client is a prominent med tech company specializing in the development, production, and distribution of radiation therapy systems and devices. With a workforce exceeding 900 people worldwide and an undeniable global presence, it has stayed committed to creating faster, more effective, and safer treatments options for patients around the world.
Responsibilities: Main responsibilities:
Reports to: Vice President of Regulatory & Government Affairs
Represent Regulatory & Quality on the commercial Region leadership team.
Champion Quality initiatives and needs for the Region with corporate functions.
Communicate with business leaders and regulatory team the impact of regulatory developments.
Align Region quality systems and processes with corporate.
Provide visibility to Region leadership of operational activities within the Region, and ongoing Quality initiatives impacting the Region.
Partner with Region leadership to ensure regulatory and quality strategies meet revenue plans and objectives.
Build and execute product and facility submission plans for the Region.
Collaborate with Regulatory Affairs Program Managers to provide product inputs and ensure product development processes support global registrations.
Manage regulatory reporting and government correspondence for adverse events and recalls.
Create and sustain systematic regulatory intelligence and lead processes to translate intelligence into process or product requirements. Build systems to identify relevant evidence, documentation and certification requirements in the Region.
Lead cross-functional teams in responding to or implementing new regulatory requirements, ensuring that the company can succeed through regulatory developments.
Manage consultants and distributors to develop submission priorities and support product registrations in indirect markets.
Develop and manage team of regulatory and quality professionals to pursue excellence in quality, regulatory affairs, and regulatory intelligence.
Engage in regulatory advocacy to support the company's positions and strategies and improve patient access to products and technology.
Ensure documents and records are filed and maintained to demonstrate compliance to regulatory requirements and preserve organizational knowledge.
Represent Regulatory & Quality activities in the Region in external audits.
Assist as needed in other activities within the Department.

業務内容：
レポート先: VP, Regulatory & Government Affairs
同社Regulatory & Qualityを代表し、コマーシャルリージョン※のリーダーシップチームに参加する。※４つのコマーシャルリージョン（Americas/EIMEA/APAC/Japan）に分類されており、本職務はJapan Regionのリーダーシップチームの一員となる。
リージョンの品質に関する取組とニーズをコーポレート部門と共有する。
ビジネスリーダーおよび薬事チームと、規制の進展による影響についてコミュニケーションをとる。
リージョンの品質システムとプロセスをコーポレートと整合させる。
リージョンリーダーに対し、リージョン内の業務活動やリージョンに影響を与える継続的な品質改善取組を可視化する。
リージョンリーダーと協力し、規制・品質戦略が収益計画や目標を達成できるようにする。
リージョンの製品及び施設申請計画を構築し、実行する。薬事プログラムマネージャーと協力し、製品インプットを提供し、製品開発プロセスがグローバル登録をサポートするようにする。
有害事象およびリコールに関する規制当局への報告および政府への対応を管理する。
体系的な規制情報を作成・維持し、情報をプロセスまたは製品要件に変換するプロセスを主導する。リージョンの関連エビデンス、文書、認証要件を特定するシステムを構築する。
新たな規制要件への対応や実施において部門横断的なチームをリードし、同社が規制の進展を通じて成功できるようにする。
コンサルタントや代理店を管理し、間接市場における申請優先順位を策定し、製品登録をサポートする。
品質、薬事、薬事インテリジェンスにおける卓越性を追求するために、薬事および品質の専門家チームを育成・管理する。
同社の立場と戦略を支援し、製品と技術への患者アクセスを改善するために、規制当局への働きかけを行う。
規制要件への準拠を証明し、組織的な知識を保持するために、文書および記録が確実に提出され、維持されるようにする。
外部監査において、地域における同社の規制・品質活動を代表する。
必要に応じて、部門内のその他の活動を支援する。

臨床開発※責任者候補

転勤なし／完全週休二日制

8 - 12 million yen Kansai Medical Device Regulatory Affairs (RA)

Company overview: We are a venture company dedicated to developing medical devices. We focus on developing an AI-powered pain assessment assistance system. We are pioneering the use of brainwave technology for automatic pain detection, receiving high acclaim globally. Founded based on research results from Osaka University, we are committed to developing assistance systems that provide objective indicators of pain. We strive to support medical staff in managing post-operative pain and alleviate patient burdens. Additionally, we are working on developing hardware that minimizes patient discomfort, aiming for devices that are easily adopted in medical settings. Our goal is to achieve the global standard in pain treatment through our ongoing research efforts.
Responsibilities: 業務内容
：
臨床開発部部門の責任者として、薬事承認に向けた各業務をプレイングマネジャーとしてお任せいたします。
詳細業務
：薬事承認や保険収載に向けた戦略立案や遂行
当局等関係各所との面談、資料作成、申請業務（新規、一変等）
法令順守関連業務（薬機法や関連法のタイムリーな情報収集、社内導入）
KOL対応（探索、巻き込み、議論）など
※国内薬事承認に関しては、コンサルの方と協業しながら業務を進めていきます。

Regulatory Affairs Specialist | 薬事スペシャリスト

Facilitate the successful intro of new products or tech

6.5 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: Our client is a prominent med tech company specializing in the development, production, and distribution of radiation therapy systems and devices. With a workforce exceeding 900 people worldwide and an undeniable global presence, it has stayed committed to creating faster, more effective, and safer treatments options for patients around the world.
Responsibilities: Main responsibilities:
Report to: Manager, Regulatory Affairs & Quality Assurance
Shonin approval of Class III medical equipment
Collaborate with the overseas manufacturing organization for collecting information or discussing regulatory-related matters
Assisting safety- and quality-related tasks
Government license-related tasks (manufacturing, repairing, selling etc)
Assisting regulatory-related compliance matters

業務内容：
医療機器（クラス3）の製造販売承認申請業務を遂行する。
薬事品質保証部の一員として製造販売業者における安全管理業務及び品質保証業務等の業務を遂行する。
報告先／所属：薬事品質保証部マネージャー
医療機器（クラス3）の承認申請業務
薬事申請業務における海外製造元との情報収集、連携、折衝等の業務。
安全管理業務及び品質保証業務補助。
業態（製造販売業、修理業、販売・貸与業等）管理業務
薬事コンプライアンス業務（社員教育等）補助。

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）

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）

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

【滋賀・京都】薬事申請（グローバル担当）◆管理職候補／糖尿病検査のトップクラスメーカー／年休121日

語学と薬事経験を活かせるチャンス

5.5 - 7 million yen Kansai Medical Device Regulatory Affairs (RA)

Company overview: Our client is a global manufacturer that represents the Kansai region and boasts a global share in clinical testing systems.
Responsibilities: ■業務内容：国内外の薬事申請業務（検査用医療機器・体外診断用医薬品）
各国薬事関連法対応、行政対応、その他開発部門へのヒアリング・調査など
※英語力やご経験によっては、海外薬事をご担当いただける場合もございます。※担当企業の国への出張が発生する可能性があります。
■配属先について：配属予定の品質本部薬事チームには10名程度が在籍し、グローバル担当は京都研究所、中国薬事担当は本社にて勤務しています。
年次問わず昇格可能な実力主義かつ、穏やか・誠実・真面目な社風です。

■ミッション：グローバルな製品展開の加速に向け部門の強化を進めております。
各国でのスムーズな上市に向けての迅速対応はもちろん、世界で最も規制の厳しい欧州での規制の先を行くような品質レベルの実現にむけてチャレンジしています。

【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）

RA Specialist (domestic and Europe)

Japanese multinational IVD maker

6 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We are engaged in the medical field, specializing in clinical diagnostics. As a leading company in the industry, we provide valuable technologies and biomarker products. Our mission is to create new value in the healthcare market and contribute to the future of health and medicine. Since successfully commercializing products such as the syphilis test kit "Syphilis HA Antigen (TPHA)," we have been involved in research, development, manufacturing, and marketing, bringing innovation to the global clinical diagnostics industry. Particularly as a leading company in the field of immune sera, we have significantly contributed to medical advancement through the development of highly sensitive automated immunoassay instruments and dedicated reagents, as well as the development of rapid immunodiagnostic kits. We have garnered worldwide attention by swiftly succeeding in the development of a rapid antigen test kit for the novel coronavirus (SARS-CoV-2), demonstrating our commitment to providing highly socially impactful and necessary products.
Responsibilities: 体外診断用医薬品・医療機器の薬事申請業務
業許可関連登録管理業務
薬事関連規制情報収集
その他法規制対応

Manager Commercial Q&R IMEA & Asia

World leader in Diabetes Care and IVD

6.5 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)

Company overview: We are a leading biotech company in the healthcare industry, attracting attention for our excellence. We specialize in diagnostic pharmaceuticals and equipment, taking charge of the diagnostic segment within our group. As one of the pillars of our operations, we focus on providing high-quality and accurate diagnostic products for a wide range of diseases, including cancer, cardiovascular diseases, and infectious diseases.
Responsibilities: 製品（血糖自己測定器及び試験紙、インスリンポンプ、穿刺機器、アプリ等）の薬事申請担当者として以下の業務を行っていただきます。
製品導入関連部署と連携して、合理的な薬事導入戦略の立案
PMDA相談等の実施、行政（厚労省、PMDA）担当者との折衝を通して、論理的かつ効率的に体外診断用医薬品、医療機器（プログラム医療機器を含む）の製造販売承認等の申請および取得を遂行する
既存製品の承認維持（一変、軽微変更）に関する薬事業務の実施
社内での薬事関連業務（Global Regulatory Teamとの連携、包材・各種資料の確認など）の実施
QMS適合性調査の対応
業許可の維持管理
外国製造業者登録の維持管理
品質システムの運用に関する業務サポート

Jobs list of Medical Device & Regulatory Affairs (RA)

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