Stryker hiring Senior Specialist, Safety Vigilance • Remote (Work from Home) | Himalayas
StrykerST

Senior Specialist, Safety Vigilance

Stryker Corporation is an American multinational medical technologies corporation that offers innovative products and services in MedSurg, Neurotechnology, and Orthopaedics to help improve patient and healthcare outcomes.

Stryker

Employee count: 5000+

Japan only
Work Flexibility: Hybrid or Onsite

Lead SpecialistもしくはSenior Specialistにて募集しております。

<Lead Specialist>

マネジャーの最小の指導の下、薬機法全般についての知識と経験を有し、円滑な安全管理業務の遂行を目的とする。複雑な案件にも対処する。

当社が販売する製品に係る安全管理業務の適切な履行を職責とし、以下の事項を含む。

・医薬品医療機器等法ならびにGVP省令を遵守した業務

・安全管理情報に関わる受付処理から完了までの一連の業務(以下を含む)

-行政当局への不具合報告ならびに渉外

-苦情品の調査に係る外国製造業者との折衝、調査対象品の返送、調査報告書の作成

-当社システムを利用した安全管理情報の処理及び管理

-社内関連部門との協働(顧客対応に関する関連部門の調整役を担う)

・社内関連部門との積極的なコミュニケーション(情報の共有と協力体制の確立)

・その他渉外(行政対応、業界対応)

Qualification

・医薬品医療機器等法全般の理解

・語学力(英語によるコミュニケーションが口語・メールを含め問題なく実施できる)

・ビジネス文書作成スキル

・一般的なPCスキル(エクセルのVLOOKUP関数や、ピボットテーブル等の実務経験がある)および、新たなシステムなどを学ぶ意欲、興味がある。

・社内外とのコミュニケーションスキル

・強力なプロジェクトマネジメントスキル

Education and experience

・工学、科学、または関連分野の学士卒以上が望ましい

・医用電気機器(ME機器)メーカーでのQA/VS/QC経験8年以上、医用電気機器の設計、開発の経験者または、医療機器、工学系に関する知識・経験があれば望ましい。

<Senior Specialist>

マネジャーの少ない指導の下、薬機法全般についての知識と経験を有し、円滑な品質保証業務の遂行を目的とする。

当社が販売する製品に係る安全管理業務の適切な履行を職責とし、以下の事項を含む。

・医薬品医療機器等法ならびにGVP省令を遵守した業務

・安全管理情報に関わる受付処理から完了までの一連の業務(以下を含む)

-行政当局への不具合報告ならびに渉外

-苦情品の調査に係る外国製造業者との折衝、調査対象品の返送、調査報告書の作成

-当社システムを利用した安全管理情報の処理及び管理

-社内関連部門との協働(顧客対応に関する関連部門の調整役を担う)

・社内関連部門との積極的なコミュニケーション(情報の共有と協力体制の確立)

・その他渉外(行政対応、業界対応)

Qualification

・医薬品医療機器等法全般の理解

・語学力(英語によるコミュニケーションが口語・メールを含め問題なく実施できる)

・ビジネス文書作成スキル

・一般的なPCスキル(エクセルのVLOOKUP関数や、ピボットテーブル等の実務経験がある)および、新たなシステムなどを学ぶ意欲、興味がある。

・社内外とのコミュニケーションスキル

・強力なプロジェクトマネジメントスキル

Education and experience

・工学、科学、または関連分野の学士卒以上が望ましい

・医用電気機器(ME機器)メーカーでのQA/VS/QC経験3年以上、医用電気機器の設計、開発の経験者または、医療機器、工学系に関する知識・経験があれば望ましい。

Travel Percentage: None

About the job

Apply before

Posted on

Job type

Full Time

Experience level

Senior

Location requirements

Hiring timezones

Japan +/- 0 hours

About Stryker

Learn more about Stryker and their company culture.

View company profile

Stryker's story begins in 1941, when Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo, Michigan, found that certain medical products were not meeting his patients' needs. Driven by a desire to improve patient care, he invented new ones. As interest in these innovative products grew, Dr. Stryker founded The Orthopedic Frame Company to manufacture them. His initial inventions, such as the Turning Frame (a mobile hospital bed that allowed for repositioning of injured patients while maintaining immobility) and the cast cutter (an apparatus that removed cast material without damaging underlying tissues), laid the foundation for a company dedicated to making surgery and recovery simpler, faster, and more effective. The company's early years were characterized by this spirit of innovation and a commitment to addressing unmet medical needs.

In 1964, the company officially changed its name to Stryker Corporation, reflecting its expanding product lines and growing ambitions. A significant milestone occurred in 1979 when Stryker made an initial public offering of stock, providing the capital for further expansion and strategic acquisitions. This marked the beginning of a period of substantial growth, as Stryker strategically acquired companies like Osteonics Corporation, entering the market for replacement hip, knee, and other orthopedic implants. Throughout the following decades, Stryker continued to diversify its portfolio through acquisitions, venturing into new medical specialties such as neurotechnology, spinal surgery, and endoscopy. By the turn of the millennium, Stryker had established itself as a major player in the medical technology industry, being included in the S&P 500 and Forbes Platinum 400. Today, Stryker is a global leader in medical technologies, offering a diverse array of innovative products and services in Orthopaedics, Medical and Surgical (MedSurg), and Neurotechnology and Spine. With a presence in over 75 countries and impacting more than 150 million patients annually, the company remains true to Dr. Stryker's original mission: 'Together with our customers, we are driven to make healthcare better.' This enduring commitment to innovation and patient outcomes continues to fuel Stryker's growth and its position at the forefront of the medical technology field.

Employee benefits

Learn about the employee benefits and perks provided at Stryker.

View benefits

Accident insurance

Insurance for accidents.

401(k) plan

Retirement savings plan.

Dental Insurance

Coverage for dental care.

Vision Insurance

Coverage for vision care.

View Stryker's employee benefits
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Stryker

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