Senior RA Specialist
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- 23000K7M Numéro de demande de personnel
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- Apr 22, 2024 Date de publication
Careers that Change Lives
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Should you be looking for the opportunity to be on the cutting edge of medical devices regulatory affairs, apply now and we’d be happy to hear from you!
The Sr Regulatory Affairs Specialist will be based in our Glass Tower, Seoul office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing, and legal compliance of a range of our medical devices to control their safety and efficacy mainly for all products. You will be an experienced Regulatory Affairs Specialist, having had min 6 year’s relevant experience preferably within the medical devices industry. It is a wonderful opportunity over time, to take your monitoring career towards your career growth in medical technology and device research.
At Medtronic, you will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.
A Day in the Life
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
- Monitors and improves tracking / control systems
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
- Direct communication with global stakeholders
- Work in collaboration with KGMP
- Regular registration status update to global and local stakeholders
Must-Have
- Completed Bachelor's degree in any discipline
- 6 - 8 years of experience in a regulatory affairs role in medical devices industries
- Good understanding and working knowledge of QARA Operations
- Must have effective written and verbal communication skills in both English and Korean languages
- Excellent stakeholder relationship management
- Achievement oriented and ability to drive results with the highest quality standards
- Computer skills (excellent knowledge of MS Office products)
Nice-to-Have
- Medical devices and class IV product licensing experience is highly regarded
- Korea Good Manufacturing Practice experience is a great plus
We Offer
In our 5th Tenet of our Mission, we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. Also, a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:
- Flexible working environment.
- Annual Incentive Plan % depending on company results.
- Pension scheme and group discount on healthcare insurances
- Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
- Employee Assistance Program and Recognize! (our global recognition program)
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services, and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.
