RA Specialist / Senior Specialist
Exciting Regulatory Affairs Specialist / Senior Specialist job opportunity ideal for an aspiring Regulatory Affairs Specialist or Senior Specialist, who wishes to hone her/his skills at a Top Medical Device Company with innovative medical devices.
Their products cover a wide range from medical devices used for the heart to neurology and urology. Always striving for innovation to improve the patients' lives, this company provides the perfect environment to learn about a vast variety of products used around the world.
As a Regulatory Affairs Specialist / Senior Specialist you are responsible for regulatory submissions for a wide range of medical devices including devices for the heart such as pacemakers and catheters to endoscopic devices such as guide wires and stents.
- Responsible for timely and rapid approvals for product lines through plans on all product registration
- Responsible for managing all product registrations' preparation and documentation
- Facilitate approval of pending registrations through communication with Regulatory agency personnel and answer any product questions
- Serve as a regulatory expert to government regulatory agencies and marketing team
- Complete the mandatory Quality training subject and ensure compliance with the internal quality system and policy
<Rewards & Benefits>
- Competitive salary package and bonus system
- Working at most famous Medical Device Company
- Being able to work with very innovative and famous products
- Flex time
- Work-live balance
- Great Benefit system and compensation plans
- 5 years' experience of Regulatory Affairs (薬事)
- Experience negotiating with PMDA
- Proactive, self-motivated mindset
- Communicative English
Do you want to take the step and challenge yourself as a Regulatory Affairs Specialist / Principal Specialist at a globally famous Medical Device company?
Then please contact Karina Ballerstedt (03-4520-4090 or ) or apply directly through this page. Feel free to also reach out for additional information anytime.
ご興味お持ちいただけましたら, アプライボタンを押していただき、カリナ バラーステッドまでご連絡してください。
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