Safety Specialist (Confidential)
Great "Medical Safety and Post Marketing Control Specialist ideal for an ambitious or Safety, who is looking for an opportunity to broaden his/her skills at a small / middle size Medical Device Company with state-of-art medical devices (one of the smallest implants in the Medical Device industry).
The role is responsible for receiving, documenting, evaluating, and coordinating investigations of customer complaints associated with products in Japan in accordance with the Pharmaceuticals and Medical Devices Agency (PMDA).
- Perform reportability assessments
- Conducts clinical follow ups with customers in Japan as needed.
- Provide reports to health authorities on adverse incident and recalls.
- Maintains log of reportable events
- Overseas all aspect of the complaint investigation from opening to closure
<Rewards & Benefits>
- Competitive salary package and bonus system
- Being able to work with very innovative and famous products and the best people in the industry
- Flex time and work-live balance
- Great Benefit system
- Great company culture with nicest people in the industry!
- Good business English (spoken/written) with TOEIC score 600 or higher TOEIC
- Knowledge of Ordinance #135, #169 and ISO 13485 and Japanese PMD Act
- Excellent written skills required due to frequent interaction with practicing ophthalmologists
- Prior experience with complaints management system
Are you ready for a new adventure as a Safety Specialist at one of the best small Medical Device companies?
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