Danaher Corporation RAQA Manager in Tokyo, Japan
As attached JD
RAQA Manager will handle Regulatory affairs and Quality Assurance for our products such as Medical Devices (Surgical Microscopes) and Reagents (In-Vitro Diagnostics ) etc.
RAQA Manager need to be General Marketing Supervisor in Marketing Authorization Holder as stated in PMD (Pharmaceutical and Medical Device) Act.
He/She works at the Tokyo office and also includes supervision of a pharmacist who work in the warehouse (Yokohama). This is a full-time (37.5 hours a week) role. RAQA Manager reports to LMS General Manager.
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
Discussion and negotiation with PMDA, MHLW and relevant organs.
Provide management team with regular updates on product registration and new regulations from government body.
Assure Quality Management System in place and sustain.
Manage complaint handling system, track and report quality issues to management team.
Communicate and collaborate with headquarters, Business Unit and internal Stakeholders.
Supervision of a pharmacist who work in the warehouse (Yokohama).
The operations in the warehouse are as follows:
(1) Incoming inspection of Medical Devices and In-Vitro Diagnostics.
(2) Quality Management System documentation.
(3) Preparation for and handling External Audits.
(4) Handle defect products found at incoming inspections.
II.REQUIREMENTS FOR THIS POSITION
Five years or more experiences of RAQA management of medical devices, medical drugs or in-vitro diagnostics
Track record in management positions with demonstrated problem solving and continuous improvement skills.
Minimum Bachelor’s degree in Engineering or Life Sciences. Advanced degree preferred
Educational and/or qualified work experience to be Sokatsu is mandatory
Pharmacist (Preferred, but not essential)
Strong written and verbal communication skills (Japanese/English: business)
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .