customer advocacy specialist 医療機器 安全管理 gvp.

Lead the development and implementation of GVP processes for a dynamic, innovative medical device company. Join a purpose-driven team and make a real impact on patient lives!■About the companyOur client is a global leader in the medical device industry, known for its commitment to innovation and patient care. They offer a collaborative and supportive work environment, with long-term career prospects and opportunities for professional growth.■Role & ResponsibilitiesAs the Customer Advocacy Specialist, you will play a pivotal role in ensuring the safety and compliance of our client's medical devices in the Japanese market. You will be responsible for establishing, maintaining, and improving the Good Vigilance Practice (GVP) process, managing adverse event reporting, and collaborating with regulatory agencies. You will be at the forefront of ensuring the highest standards of safety and compliance are met.■Main tasks include・Establish and maintain the Good Vigilance Practice (GVP) process for the Japanese market.・Gather, analyze, and report on adverse events related to medical devices.・Prepare and submit regulatory reports to relevant agencies.・Ensure compliance with medical device regulations and guidelines.・Collaborate with cross-functional teams to drive continuous improvement.■What you’ll get: ・A front row seat to life changing CGM technology. Learn about our brave warriors community.・A full and comprehensive benefits program.・Growth opportunities on a global scale.・Access to career development through in-house learning programs and/or qualified tuition reimbursement.・An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.■Travel Required:5-15%If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・Minimum of 3 years of experience in complaint handling and vigilance reporting in the medical device or IVD industry.
・Proven ability to perform routine tasks with accuracy and attention to detail.
・Excellent problem-solving and analytical skills.
・Effective communication skills in English and Japanese (written and verbal).
・Ability to read, interpret, and write reports and correspondence.
・Experience working within a regulated environment (e.g., ISO 13485).
・Strong understanding of medical device regulations in Japan.
・Adaptability and flexibility to changing priorities.
・Bachelor's degree in a relevant scientific or engineering field.
・Experience with global regulatory reporting systems is a plus.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収600 ～ 800万円

賞与
11%
雇用期間
期間の定めなし