RA Specialist SPECIAL PROJECTS
3주전에
[MedTech] RA Specialist SPECIAL PROJECTS W
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .
- : Regulatory Affairs Specialist Special Projects
- : (MedTech)
- :
- : Fixed Term(1 year)
[Responsibilities]
- Takes charge in products for assigned projects.
- Prepares and submits required regulatory applications for new products for replacement, change of manufacturing process
- Monitors and submits regulatory applications for changes of approved products
- Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters
- Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
- Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc.
- Researches and consolidates regulatory requirements and communicate their information with supervisor and manager.
- Supports the RA team in projects.
- Supports in the development of best practices for Regulatory Affairs processes.
- Conforms regulatory compliance.
- The incumbent must have the ability to work effectively and process requests/work within required timeframes.
- A team player with a diligent and sincere attitude and mindset
- Has a strong sense of responsibility on meeting due/target and quality/integrity/accuracy of the output
- Views new and ambiguous challenges as a learning opportunity
[Requirements]
- A minimum Bachelors degree is required.
- Minimum 3 years of progressive RA experience in HealthCare industry is preferred.
- Knowledge of regulatory environment, relative law and regulations on Medical Devices.
- Understanding of regulatory requirements.
- Prefer holding a Regulatory Affairs Certification (RAC)
- Experts in MS Word, Excel, Power Point and HWP etc.
- Good at writing and translation skill in English
- Less than 10% travel (oversea and domestic)
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Qualifications
See above.
Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization Johnson & Johnson Medical Korea (Ltd
Job Function Project/Program Management
Req ID: W
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