Regulatory Affairs Specialist

Job Summary

Regulatory Affairs Specialist is responsible for obtaining approvals and registrations of our mission-critical products in S. Korea and ASEAN countries. Person in this role will coordinate with regional counterparts on products to maintain up-to-date information on local regulatory requirements. The incumbent’s medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people’s lives.

The ideal candidate brings strong regulatory expertise, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.

Duties and Responsibilities:

• Prepare the documentation for new product registration, update & renewal of existing product licenses, and KGMP certifications with MFDS;
• Assist in filing and maintaining product and establishment registrations with QIA, animal health regulatory authority;
• Communicate with ASEAN regional counterparts to coordinate registration strategies and support new product registration, update & renewal of existing product licenses, and compliance to local quality requirements;
• Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies in ASEAN region;
• Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements in ASEAN region;
• Maintain up-to-date knowledge on domestic and ASEAN region’ regulatory requirements and provide appropriate guidance within the organization;
• Communicate with regulatory agencies and testing labs in Korea;
• Communicate with commercial and marketing team to support tender request and reimbursement questions;
• Communicate with Corporate regulatory team and manufacturing sites to get the required documents and product information;
• Performs other regulatory related duties or special projects as assigned

Minimum Qualifications and Experience:

• A minimum of 2 years of RA experience in medical device manufacturing or importing companies;
• Working knowledge of MFDS and/or ASEAN region regulations.
• Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
• Language: Fluent English speaking, writing, and reading;
• Excellent verbal and written communication skills;
• Excellent prioritizing, organizational, and interpersonal skills;
• Excellent documentation skills including record maintenance/ tracking and understanding document traceability;
• A detail-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision;
• Ability to work in a fast-paced environment, with multiple tasks/projects

Preferred Qualifications and Experience:

• Experience in patient monitor systems, hospital-based products, software, or electronic device products;
  • Knowledge of regulatory submission requirements for medical devices, and equivalent classification requirements for ASEAN submission;
  • Experience with FDA/GMP requirements for medical device;
  • Experience in Quality Systems per ISO 13485;
  • Experience with animal health product registration process

Education:

Bachelor’s degree or higher is required, preferably in Engineering, Biosciences, Chemistry, or equivalent field

Physical Requirements/Work Environment:

This position primarily works in an office environment. Daily use of a computer and other computing and digital devices is required. Some local or overseas travel may be necessary, so willingness/ability to domestic or international business trip is required.