Amazing job opportunity for a QARA Manager who is looking for an opportunity to broaden his/her skills at a Global Medical Device Company with 90 location around the world.
As RAQA Manager you will be responsible for managing quality assurance and regulatory affairs function for Japan.
Acquiring regulatory approval of advanced medical device products and handling product complaint issues are the critical responsibilities of the role. The position is responsible for securing global consistency of the RA&QA function and closely collaborating with the Global QA & RA team.
- Acquire regulatory approval of Class I medical device products as soon as scheduled through thoughtful strategy development, effective communication with both external and internal partners, and productive agency interface with governmental organization, such as Tokyo Metropolitan Government/Ministry of Health (PMDA Pharmaceutical & Medical Device Agency), Law and Welfare.
- Monitor and advise Global RA & QA on proposed and existing legislation and regulatory developments affecting Hollister Japan's business.
- Work effectively with the Global RA team to manage medical device safety reporting.
- 8 years of QARA experience
- Both QA & RA experience at global medical device/healthcare company, including hands on regulatory submission experience and management experience.
Are you ready for a new adventure as a QARA Manager in a respectable American company with 90 location around the world?
Please kindly apply or call Monika Ambroziak (03 4520 4041)
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja