RA/QA Specialist

求人詳細

Position: RA/QA Specialist

Position Overview
We are seeking an experienced Regulatory Affairs & Quality Assurance Specialist to join our team, focusing on regulatory submissions and compliance for dental medical devices. This role offers opportunities for career growth within a global organization.

Primary Responsibilities
● Manage regulatory submissions and related activities for dental products (devices, materials, implants)
● Ensure compliance with Pharmaceutical and Medical Device Act (PMD Act)
● Obtain manufacturing/marketing approval and certification for medical devices (Class I-III)
● Handle amendments and notifications for existing approvals
● Manage manufacturing site registrations under PMD Act
● Prepare and submit insurance coverage applications
● Collaborate with global stakeholders including design, development, quality assurance, and marketing teams

Key Stakeholder Interactions
● Headquarters (Europe/Americas): Design, Development, QA, and Marketing teams
● Domestic: Sales, Marketing, and Service departments

こんな方を求めています

経験・スキル

Required Qualifications
● Experience in regulatory affairs for medical devices
● Business-level English proficiency (reading, writing, speaking)

Preferred Qualifications
● Experience with dental product regulatory submissions
● Experience with implant product regulatory submissions

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 600 〜 800万円

賞与

Variable

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険,介護保険,労災保険

受動喫煙防止措置

敷地内禁煙

特長

上場企業, 外資系企業, フレックスタイム制, 完全週休2日制, 土日祝休み, 語学力を活かす

業種

医療機器・医療品関連

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