概要
THE COMPANY and BUSINESS
With a more than 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology. Cordis established a legacy of high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in countries around the world. But we're not stopping there.
We are innovators at heart
In March of 2021, private equity firm Helman & Friedman announced the purchase of Cordis in recognition of its enormous growth potential, committing to a $300 million investment to accelerate innovation. Building on our storied brand, we are unleashing our potential to be a $10 billion leader and transform the market bringing new technology through bold action at speed.
People are the heart of our business
We are teammates, not just employees. Empowered to act as owners, our teammates deliver excellence in service of our mission: to delight our customers. Cordis is both a place to fulfill your career aspirations and a bigger purpose. Each teammate contributes to the wellbeing of millions of patients who enjoy healthier and longer lives as a direct result.
Diversity and inclusion are foundational to our values and successes. The richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately the lives of our patients.
職責
Job Summary
This position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals.
Keep the good relationship with related authorization agencies.
- Develop and implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations (includes product with clinical data)
- Author product submission/notification, correspondent letter to authority
- Directly communicate with local authority (MHLW/PMDA) upon implementing regulatory strategy and correspondent on submissions.
- Monitor regulation, policy and standard changes from government authorities that have impact to company's products.
- Assess regulatory impact on various product/process change
- Submit partial changes or change notifications to approved products to PMDA as required.
- Author reimbursement submission document
- Review and approve advertising/promotional material to assure compliance with governing advertising/promotion
- Collaborate with necessary internal/external source to proceed assigned projects
- Attend related industry meetings to gather latest information and input necessary company opinion with internal cross functional alignment
- Performs other duties as needed
資格
Qualifications
Education & Experience
- Bachelors in related field or equivalent work experience, Science and Engineering background preferred
- 7+ years' experience in medical device Regulatory Affairs including submission with clinical data, experience working with PTA-related products (CLASS-IV) is preferred
- Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data, experience working with PTA-related products is preferred
- Prior experience on B1/B2/B3/C1 and C2 reimbursement submission preferred
- Knowledge and experience with manufacturing control and quality control under requirements of QMS ministry ordinance in medical devices industry. (Experience as a general manager of MAH(SOKATSU) or a domestic quality manager(KOKUNAI-HINSEKI) required by PMD-Act are even more desirable)
- Knowledges and experiences with ISO
Skills
- Comprehensive knowledge of current regulations and guidelines
- Fluent in Japanese/English reading, writing and communication
- Familiar with MS Office applications
- Strong project management skills
- Ability to adapt constant changes in fast pace
#LI-DW1
-
Tokyo BD ￥9,000,000 - ￥12,000,000 per year+仅：department · ） +先 · ...
-
Tokyo, Tokyo Parexel ￥1,500,000 - ￥2,500,000 per yearパレクセルコンサルティング(薬事部門)は、主に海外のバイオテックカンパニーをクライアントとして、新薬開発計画の戦略プランからPMDA相談、申請、承認取得までのサービスを提供しております。 · クライアントの窓口となり、業務依頼(Statement of Work、予算、要求、期待値)を確認し、プロジェクトの範囲と要件を理解。 · 必要に応じ、クライアントとの会議を設定、ファシリテートし、薬事サービスに関するニーズ、問題点につき話し合い、戦略的計画を立てる。 · プロジェクトチームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト ...
-
Minato-ku BD Full time￥6,000,000 - ￥12,000,000 per year호소는 정을 안세요 - · BD's Life Science Department (BioScience and Diagnostic Solutions Business) is integrating with Waters to become a leading company in the life science and diagnostic fields, specializing in high-volume testing in a highly regulated market. · ...
-
Shinjuku Cordis Full time￥5,000,000 - ￥10,000,000 per yearThis position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsi ...
-
Tokyo BD ￥2,024,000 - ￥30,000,000 per year当社のライフサイエンス製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · 製品登録プロジェクトのリード · (医薬品医療機器等法)に基づく登録申請書類の作成・提出 · 償還関連業務 · 区分の償還申請書類の作成・提出、E2・E3区分の償還取得サポート · 製品ラベリングのレビュー・承認 · 登録書類と整合性を保つためのラベルや関連資料の確認 · 広告・販促資材(AdProm) のレビュー・承認 · 事業部門:ビジネス戦略を理解し、薬事戦略や進捗を共有 · Regulatory(海外):製品登録に必要な情報のはて ...
-
Tokyo Parexel Full time￥6,000,000 - ￥12,000,000 per yearパレクセルコンサルティング(薬事部門)は、主に海外のバイオテックカンパニーをクライアントとして、新薬開発計画の戦略プランからPMDA相談、申請、承認取得までのサービスを提供しております。 · クライアントの窓口となり、業務依頼(Statement of Work、予算、要求、期待値)を確認し、プロジェクトの範囲と要件を理解。 · 必要に応じ、クライアントとの会議を設定、ファシリテートし、薬事サービスに関するニーズ、問題点につき話し合い、戦略的計画を立てる。 · プロジェクトチームの発足からプロジェクト終了までの全てのプロセスにおいて、タイムライン、コスト ...
-
Tokyo, Tokyo GE HealthCare ￥6,000,000 - ￥12,000,000 per yearWe are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, regulatory submissions, and post-market activities, whi ...
-
Tokyo Revolut ￥5,000,000 - ￥15,000,000 per yearWe are looking for a Regulatory Affairs Manager to lead our team in Japan, responsible for maintaining and building transparent relationships with regulatory authorities. The successful candidate will have experience in the financial industry, particularly in regulatory affairs, ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Regulatory Affairs
2週間前
Tokyo, Japan ZOLL Medical $90,000 - $120,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...
-
Regulatory Affairs
1週間前
Tokyo ZOLL Medical Corporation ￥5,500,000 - ￥10,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Tokyo Michael Page ￥3,500,000 - ￥7,000,000 per yearアジア・欧州など75以上の国と地域に展開する製品に関与 · 革新的で患者中心の製品を提供するヘルスケア企業。世界75以上の市場で展開しており、科学的根拠に基づいた製品ポートフォリオを持つ成長企業です。 · 日本市場における薬事戦略の立案・実行 · 製品登録・維持管理、申請スケジュールの策定と進捗管理 · 薬事関連法規(PMD Act等)の情報収集と対応 · 新製品導入に向けた薬事支援、技術情報の収集・提供 · グローバル・ローカルプロジェクトへの参画・支援 · ...
-
Japan - Tokyo Amgen ￥1,500,000 - ￥2,000,000 per yearThe Associate Director of Regulatory Affairs will oversee regulatory strategies and interactions with key agencies in Japan. · ...
-
Tokyo Planet PharmaThe opportunity to develop regulatory strategy, prepare and execute regulatory submissions for innovative products in Japan, with a strong understanding of local regulatory requirements and experience leading regulatory activities. · Create proactive and robust regulatory strateg ...
-
Tokyo Specialized Group ￥10,000 - ￥40,000 per yearWe are looking for an Associate Project Manager to join the President's Project Management Office of a leading company in the medical device industry. · ...
-
Japan Colgate ￥5,000,000 - ￥10,000,000 per yearResponsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. Develops creative approaches and strategies to solv ...
-
Tokyo ICON plc ￥800,000 - ￥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Japan Ceva Sante Animale ￥2,500,000 - ￥5,000,000 per yearAs a Regulatory Affairs Manager, you will ensure regulatory submissions and post-licensing compliance for Ceva products in Japan. You will coordinate activities, apply regulations, and develop a regulatory strategy. You will also manage quality systems, pharmacovigilance activiti ...
-
Tokyo Jobs via eFinancialCareers ￥2,500,000 - ￥5,000,000 per yearプロジェクトマネージャーを求めています。医療機器業界のトップ企業のプレジデントのプロジェクトマネジメントオフィスに参加することになります。この役割は、オフィスとリモートワークの両方を組み合わせたもので、20日間の有給休暇とキャリア成長のための明確なパスを提供します。重要なプロジェクトに貢献するために準備ができている人に適しています。 · ...
-
Tokyo, Tokyo Merck Healthcare ￥5,000,000 - ￥10,000,000 per yearDevelop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group 1 or Group 2: ...
-
Tokyo, Tokyo Planet Pharma ￥4,000,000 - ￥8,000,000 per yearThe Senior Regulatory Affairs – CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market. · Author, review, and m ...
