Regulatory Affairs Specialist II

Reporting Relationship: 

This job reports: to Manager, Regulatory Affairs. Reporting directly or indirectly to this position are the following job titles: Not Applicable.

• →

  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

• 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

   

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

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.