🌎
This job posting isn't available in all website languages

【SPINE】Sr. Regulatory Affairs Specialist or Specialist_Regulatory Affairs Specialist

📁
Regulatory Affairs
📅
18000JFE Requisition #
Share this Job

JOB TITLE:Sr Regulatory Specialist 又はRegulatory  Specialist

DEPARTMENT: JAPAN Rgulatory Affairs  Spine担当

REPORTING TO:  Regulatory Affairs  Manager

 

LOCATION:Tokyo/Osaka

 

Main Mission of Job

新製品の本邦への導入及び既存製品の維持を行うことで医療現場に品質及び安全性の高い製品を提供する。


Main Responsibilities

A Day in the Life

Medtronic SPINE事業部では、超高齢社会において増加し続ける椎間板ヘルニアや腰部脊柱管狭窄症、骨粗鬆症による圧迫骨折など、脊椎疾患の治療に用いる脊椎インプラントや内視鏡、バルーンを用いた矯正など、新しい手術手技やソリューションを提供しています。薬事業務をとおして、様々な経験の出来るチャレンジングな分野です。

 

主な業務内容:

1.    医療機器の薬事申請関連業務(届出、認証、承認を含む)

2.    当局又は認証機関との折衝(照会対応を含む)

3.    米国製造元及び社内関連部署とのコミュニケーション及びコラボレーション

4.   保険収載業務(保険適用希望書作成等)

 

Must Haves

Knowledge/Education

・理系大卒以上または同等の専門教育修了者以上

・医薬品医療機器等法に関する基本的な知識

 

Job Experience

・クラス2以上の医療機器における承認・認証申請の経験 3年以上

PMDA簡易相談、対面助言の経験

 

Skills /Competencies Required

・英語力製造元と日常的なメール/電話会議等でのやり取りが発生するため

・コミュニケーション能力

・業務に積極的に、かつ、誠実に取り組む姿勢

 

Computer Skills:

PowerPoint/Word/Excel

 

Physical Requirements:

宿泊を伴う国内及び海外出張が可能なこと

 

Nice to Have

Job Experience

・工学系(機械、電気等)

・整形外科領域での薬事申請経験

PMDA簡易相談、対面助言の経験

Skills /Competencies Required

TOEIC600点レベル以上

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Tokyo, Japan

📁 Regulatory Affairs

Requisition #: 18000KNS

Tokyo, Japan

📁 Regulatory Affairs

Requisition #: 18000MV6

Tokyo, Japan

📁 Regulatory Affairs

Requisition #: 18000IA0

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.