Regulatory Affairs Specialist

This position will serve as RA specialist at Cook Medical Korea and have responsibilities for supporting to renew MFDS approval of existed products and register our new product to MFDS.

The position reports to RA Director of Korea and primary responsibilities include, but are not limited to:

• To get MFDS approvals to facilitate and ensure smooth and timely introduction of new products according to SBU needs.
• Utilize and maintain programs used by RA such as RIMS, etc.
• Maintain requests through RA group email.
• Provide status report and submission and approval status of registration to RA Director.
• Develop the appropriate strategies and proactively take an action for post-market approval, license renewal, KGMP.
• Establishes and maintains reasonable and responsible regulatory climates locally through good networking (e.g. with other cross-functional/sector/category/regional/colleagues).
• Work with Cook manufacturers to provide strategy and multiple options for meeting regulatory requirements (Provide “can do” solutions, not “cannot do” roadblocks)
• Write and review Regulatory Submissions professionally.
• Train stakeholders on Korea regulatory requirements and regulation such as sales team, Cook manufacturers, etc.
• Negotiate with local authorities on behalf of Cook objectives
• Collaborate with Quality and Reimbursement team for all submissions where applicable
• Learn the Cook Group vision and ensure regulatory compliance.

Minimum Work Experience / Educational Requirements:

• Experience in regulatory for medical device industry
• Experience in negotiating with regulatory authorities
• Experience in coworking with overseas manufacturers

Personal Attributes:

• Fluent in English, both spoken and written
• Capability to Train overseas manufacturers, attend/lead conference calls with overseas manufacturers
• Experience working for multi-national companies
• Interpersonal Skills and Team Player
• Positive attitude
• Willingness to improve job related knowledge throughout constant self-study on local/overseas regulation and active participation to industry activities.
• Organized, good management and planning skills
• Ability to work closely with people at all levels
• Excellent communication skills
• Strategic thinker with excellent time management skills
• Self-motivating
• 1-5 year RA Working experience in foreign medical device companies