Quality Assurance Manager
International Medical Devices Company with quality products
Position with responsibilities, highly skilled professional in QA
Our client, a foreign multinational company specialising in medical devices based in Tokyo, is searching for its new Quality Assurance Manager. You have in depth knowledge QSM and/or ISO 13485? You have at least 15 years of experience in QA for a medical device company? You have great interpersonal and communication skills? This job is made for you. Apply now!
For this Quality Assurance Manager position, you will be asked to
- Be responsible for all regulatory matters (regulatory affairs, Intelligence, Pharmacovigilance...)
- Review performance of all regulatory actions (new Marketing Authorisation, MAH transfers, variations, line extensions, withdrawals, product recalls, renewals etc.)
- Define the regulatory needs, develop SOPs etc.
- Facilitate GVP activities in cooperation with the QA group to ensure the appropriate implementation of safety measures
This list is not exhaustive. Other missions may be added.
To succeed in that position, you will need
- BS degree in pharmacy, engineering, science, microbiology, or related field
- 15 years of experience in Quality Assurance in a medical devices industry
- Fluent English business capability
- Great interpersonal skills and management skills