At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!Reporting to Sr Regulatory Affairs Manager, the 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. This is a fixed-term individual contributor position for 12 months.
Responsibilities may include the following and other duties may be assigned:
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.
Required Knowledge and Experience:
Completed Bachelor's degree in any discipline, preferably Bachelor's Degree in Medical/ biological science or equivalent field
1 - 6 years of experience in a regulatory affairs role in healthcare industries - Medical devices product licensing experience and / or Korea Good Manufacturing Practice experience is a great plus
Must have effective written and verbal communication skills in both English and Korean languages
Computer skills (excellent knowledge of MS Office products)
Good understanding and working knowledge of QARA Operations
Excellent stakeholder relationship management
Achievement oriented and ability to drive results with the highest quality standards
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here