RA Principal Specialist - 医療機器メーカー

Location: Tokyo
Contract Type: Permanent
Salary: ¥9000000.00 - ¥15000000.00 (年収)
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: Regulatory Affairs,
Contact: Yuya Sawaguchi
Reference: JO-2210-475726

MANDATORY
・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務

[ポジション]
RA Principal Specialist

[事業内容・会社の特徴]
外資系医療機器メーカー

[仕事内容]
Job Summary
Provide support on a range of medical device and 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
  • 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

[応募資格]
Education & Experience

  • Bachelor's Degree in related field, Science background preferred
  • 7+ years' experience in medical device regulatory affairs including submission with clinical data
  • Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data
  • Prior experience on C1/C2 reimbursement submission preferred

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

[勤務地]
東京都/リモートワーク制度あり

[勤務時間]
フレックス制度あり

[給与]
900〜1500万円(スキル・ご経験により決定)

※ご興味をおもちいただけましたら、まずはエントリーをお願いいたします。
ご紹介できる場合は、5営業日以内に担当コンサルタントよりご連絡いたします。
詳細はその際に別途明示いたします。

Reference: JO-2210-475726
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Science, Other