BRS Consultant
Takahisa Hitotsumatsu
Medical Device
Job number: JN -072024-36442
Posted: 2024-09-11
Quality Assurance Specialist
癌領域の病理リーディングカンパニーでのQAポジション
8 - 11 million yen
Tokyo
Medical Device
Quality Assurance / Quality Control
Job details
- Company overview
- We import and sell microscopes and related equipment manufactured overseas in Japan. With a heritage dating back about 170 years, we represent a leading German precision equipment company, offering top-quality microscopes and peripherals imported and sold domestically. Through several corporate mergers since our inception, we emerged in 1990 as Leica Microsystems, a prominent European manufacturer of scientific instruments. Utilizing microscopes and associated equipment, we address the increasingly sophisticated observation, measurement, and analysis needs in the fields of life sciences and industry, providing optimal system solutions for users.
- Responsibilities
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Main responsibilities:
・Both IVD and medical device MAH Quality responsible person(Hinseki).・Both IVD and medical device MAH manufacturing manager (Seizou Sekininsha).・Lead and support for collaborating with BU and SU stakeholders to manage quality issues including support for the administration of fileld actions (Recall) and reporting in complaint system.・To update QMS documents based on local regulation modification/new release.・To lead regular internal QMS meeting and management review meeting.・To support all related LBS license (MAH IVD/medical device, poisonous substance import,medical device maintanance etc.)・To support medical writing regarding both IVD and medical device STED.・To support PMDA consultation document preparation and preparation for answers of queries from PMDA. - Requirements
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Minimum requirements:
・Minimum of 7 years’ work experience in medical or life science market.・>5 years People Management experience (Preferred).・Pharmaceutical license holder (Goverment certified Pharmacist License).・Effective communication skills in English and a client service orientation.・Excellent cross functional communication skills.・Strong business acumen in understanding commercial aspect of healthcare business.・Organized individual with strong self and project management disciplines, including the ability to lead, facilitate, influence and organize across groups and according to timelines.
Preferred qualifications:
・Knowledge of MS Excel, Word, PowerPoint for business presentation and knowledge of PMDA DTD system will be highly advantageous. - Salary
- 8 - 11 million yen
- Location
- Tokyo