社名
社名非公開
職種
薬事、メディカルライティング
業務内容
Leadership Role: As a RAQA Director, you will hold a senior leadership position within the organization. You'll have the opportunity to lead and shape the Quality Assurance and Regulatory Affairs teams, making strategic decisions that impact the company'
...
Collaboration: Collaboration is a fundamental aspect of this role. You'll work closely with various departments, including Business, Marketing, Manufacturing, and R&D, fostering a collaborative and cross-functional work environment.
Making a Difference: Ultimately, this role allows you to make a meaningful impact on healthcare in Japan by ensuring that products meet regulatory standards, are of high quality, and are safe for patients.
求められる経験
Qualifications / Education / Experience / Skills Required:
- A broad technical background, preferably a graduate-level degree in a science or engineering discipline, with a minimum of ten years of managerial experience in Quality or Regulatory Affairs.
- Extensive experience in establishing and managing compliance programs for medical devices and/or pharmaceuticals in the Japanese market.
- Proven experience working closely with Business, Marketing, Manufacturing, and R&D functions.
- In-depth knowledge of domestic and international regulations, and prior experience as a General Controller for medical devices in Japan is highly desirable.
- Minimum of six years of experience in leading and managing functional teams.
- Bilingual proficiency in English and Japanese.
Specialized or Essential Knowledge Required:
- General knowledge of Regulatory requirements, including the Pharmaceuticals and Medical Devices Act (PMD Act), MHLW Ordinances (e.g., 94, 135, 169), Standards (e.g., ISO 13485, ISO 14971), Statistical Sampling, Root Cause Analysis, and Failure Investigation Tools.
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
休日休暇
土曜日 日曜日 祝日
給与
年収1,200 ~ 2,000万円
賞与
15%
show more
社名
社名非公開
職種
薬事、メディカルライティング
業務内容
Leadership Role: As a RAQA Director, you will hold a senior leadership position within the organization. You'll have the opportunity to lead and shape the Quality Assurance and Regulatory Affairs teams, making strategic decisions that impact the company'
Collaboration: Collaboration is a fundamental aspect of this role. You'll work closely with various departments, including Business, Marketing, Manufacturing, and R&D, fostering a collaborative and cross-functional work environment.
Making a Difference: Ultimately, this role allows you to make a meaningful impact on healthcare in Japan by ensuring that products meet regulatory standards, are of high quality, and are safe for patients.
求められる経験
Qualifications / Education / Experience / Skills Required:
- A broad technical background, preferably a graduate-level degree in a science or engineering discipline, with a minimum of ten years of managerial experience in Quality or Regulatory Affairs.
- Extensive experience in establishing and managing compliance programs for medical devices and/or pharmaceuticals in the Japanese market.
...
- Proven experience working closely with Business, Marketing, Manufacturing, and R&D functions.
- In-depth knowledge of domestic and international regulations, and prior experience as a General Controller for medical devices in Japan is highly desirable.
- Minimum of six years of experience in leading and managing functional teams.
- Bilingual proficiency in English and Japanese.
Specialized or Essential Knowledge Required:
- General knowledge of Regulatory requirements, including the Pharmaceuticals and Medical Devices Act (PMD Act), MHLW Ordinances (e.g., 94, 135, 169), Standards (e.g., ISO 13485, ISO 14971), Statistical Sampling, Root Cause Analysis, and Failure Investigation Tools.
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
休日休暇
土曜日 日曜日 祝日
給与
年収1,200 ~ 2,000万円
賞与
15%
show more