Medical Scientific Affairs Sr. Specialist / Specialist (Medical Devices)

Location: Tokyo, Japan; hybrid work model with on-site clinical visits and overnight business travel

Company

hirify.global Aesculap Japan is a medical technology and healthcare solutions subsidiary of the hirify.global Group, focused on manufacturing, selling, repairing, and importing and exporting medical equipment.

What you will do

• Collect and report clinical data required for medical device product development in Japan.
• Execute clinical development activities in line with international and local requirements, ICH-GCP guidelines, ISO 14155, company SOPs, and study-specific procedures.
• Act as the direct contact for assigned clinical sites, monitor study implementation, and ensure protocol adherence and data integrity.
• Perform on-site monitoring visits, resolve site issues, manage study documents, and support audits or regulatory inspections.
• Participate in investigator, internal, and external meetings and provide written and oral status updates to the Medical Scientific Affairs Manager.
• Support global Medical Scientific Affairs activities in Japan and build effective relationships with internal and external stakeholders.

Requirements

• Bachelor’s degree in Medical Science, Public Health, Natural Science, healthcare, or biostatistics.
• At least 7 years of experience conducting clinical studies.
• Experience with international clinical studies based on ISO 14155.
• Excellent written English communication skills are required.
• Strong interpersonal, communication, organizational, ethical, and problem-solving skills.
• Availability for overnight business travel: approximately 50% of the week during the start-up phase and at least twice per month thereafter.

Nice to have

• Experience with medical devices.
• Medical and scientific writing experience.
• Clinical knowledge or experience in neurosurgery, interventional radiology, or orthopaedic surgery.
• Strong verbal English communication skills.

Culture & Benefits

• Flexible working hours and a hybrid work style.
• Fixed bonus twice a year and an annual performance bonus.
• Comprehensive social insurance and a retirement allowance after three years of service.
• 123 days off per year and annual paid leave.
• Childcare support, reduced working hours for childcare, and a government childcare subsidy program.
• Influenza vaccination assistance and Benefit Station subscription.

Hiring process

• CV screening followed by a first interview.
• Web assessment and two to three online or in-person interviews.
• Offer and onboarding for successful candidates.