【外資系医療機器メーカー】Sr Manager, Regulatory Affairs

求人詳細

Lead regulatory strategy and compliance for innovative medical devices in a dynamic, global organization.

■About the company
Our client is a leading global medical device company driven by a passion to improve patient lives through cutting-edge innovation. With a significant presence in Japan and a commitment to collaborative teamwork, they offer a supportive and challenging environment for professionals seeking to make a meaningful impact.

■Role & Responsibilities
You will be responsible for overseeing all aspects of regulatory affairs for assigned products, ensuring timely and successful submissions to Japanese regulatory agencies. You’ll collaborate with cross-functional teams, providing expert guidance on regulatory compliance and strategic planning. You will also monitor global regulatory changes, proactively identifying and mitigating potential risks. This role offers a unique opportunity to influence product development and contribute to the success of life-saving medical technologies.

■Main tasks include
・Prepare and manage regulatory submissions to Japanese agencies (e.g., IDE’s, PDMA, PMA’s, annual reports, 510(k)’s, STED’s, CE marking).
・Represent regulatory affairs on product development and manufacturing teams.
・Develop and implement regulatory strategic plans.
・Monitor global regulations and assess their impact on projects.
・Review promotional materials and labeling for compliance.
・Provide guidance on regulatory requirements for strategic planning.

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
・Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or related field.
・5+ years of experience in regulatory affairs within the medical device industry.
・Proven expertise in preparing and submitting regulatory documentation to Japanese agencies.
・Deep understanding of Japanese regulations for medical devices (Class I-IV).
・Excellent written and verbal communication skills in English and Japanese.
・Strong problem-solving, analytical, and critical thinking skills.
・Experience working effectively in cross-functional teams.
・Experience in leading and mentoring team members is highly desired.
・Proficiency in Microsoft Office Suite.
・Master's degree in a related field is preferred.

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 1,000 〜 1,380万円

賞与

+16％

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