Sr. Regulatory Affairs Specialist I Leading Medical Device Company

求人詳細

Lead Regulatory Affairs in Japan and grow your career within a dynamic, international team.

■About the company
Our client is a well-established international medical device company with a strong presence in Japan. They are known for their commitment to innovation and high-quality products, fostering a collaborative and supportive work environment. The company offers excellent opportunities for professional development and career advancement within a global network.

■Role & Responsibilities
You will be the driving force behind regulatory submissions in Japan, working closely with Japanese authorities and internal stakeholders. You will play a key role in ensuring compliance and facilitating the successful launch of new products. This role offers the chance to make a significant impact on the company's success in the Japanese market while developing your expertise in regulatory affairs.

■Main tasks include
・Lead the preparation of applications, partial change applications, and Class 1 notifications.
・Prepare and submit QMS documentation as needed.
・Support Class IV applications and lead consultations with PMDA.
・Support regulatory assessment of change controls.
・Manage and maintain Shonin documents.
・Interact with Japanese authorities and industry groups.
・Manage reimbursement processes.
・Review promotional materials and labeling.

If you are interested in this exciting opportunity, apply now.
We look forward to hearing from you.

#LI-Hybrid

こんな方を求めています

経験・スキル

■Requirements
・Minimum 5 years of RA experience in the medical device industry; Class IV experience preferred.
・Experience with Japanese regulatory processes (PMDA, MHLW).
・Excellent written and verbal communication skills in Japanese and English.
・Strong negotiation and collaboration skills.
・Proficiency in MS Office Suite.
・Experience with ERP systems is a plus.
・Strong organizational and time-management skills.
・A science background is preferred.
・Experience at a CRO is a plus.

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 800 〜 1,000万円

賞与

yes, included

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

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

※詳細はお仕事のご紹介時にお伝えします