[What We do] The Regulatory Affairs Team is responsible for ensuring that medical devices comply with all relevant regulations and standards set by regulatory authorities, and plays a crucial role in the development, approval, and maintenance of medical devices throughout their lifecycle. The primary objective of the Regulatory Affairs Team is to ensure that medical devices meet regulatory requirements for safety, quality, and effectiveness, enabling timely market access while minimizing regulatory risks for the company. RA팀은 의료기기가 관련 규정 및 기준을 준수하는 것을 보장하며, 의료기기가 안전하고 품질이 우수하며 효과적인지 각 국가별 규제 요건을 충족시키도록 보장하는 동시에 회사의 규제적 위험을 최소화하고 시장 접근성을 확보합니다.
[Position] Regulatory Affairs Specialist
[Responsibilities] -Regulatory Affairs specialist plays critical roles throughout the ultrasound product lifecycle. He/She may work with internal & international project team and provide advice & counsels to stakeholders and perform a country registration to deliver the safe and effective ultrasound products to worldwide within regulations -[Country registration for Korea and other countries such as Japan, India, France, Qatar, USA and etc.] Prepare submission package and submit to regional RA specialist and Communicate the response from government and Maintain records on legislation, regulations, guidelines and regulatory files for each country and Update and maintain paper/electronic document archival systems -Assist quality & regulatory inspection such as ISO13485, KGMP, QMS, FDA and etc. -Provide regulatory input to product lifecycle planning and communicate regulatory information to stakeholders
-의료용 초음파영상진단장치의 규격(RA)업무 -초음파 제품 해외 인허가 취득 및 유지 관리 -허가 관련 담당국가 관리 및 지원 업무 -국내외 관련 규정 모니터링 및 적용 -RA data 관리, 소통 업무
[Requirements] -Junior/Entry level (0~3 years experience) -Bachelor’s degree in Biomedical Engineering, Electrical or Electronics engineering -Regulatory affairs experience preferred such as Korea, FDA 510(k), EU MDR and etc. -Excellent verbal and written communication and presentation skills with the ability to communicate in English
-1년이상 경력자
-영어커뮤니케이션 가능자, intermediate communication skill -4년제 대학 졸업자 (의용공학, 전기공학, 전자공학 전공자 우대) -RA 관련 학점 이수, RA 외부 교육, RA 자격증 또는 실무 경력 보유자 우대 -ISO13485, ISO14971, IEC60601-1, KGMP and etc.유경험자 우대 -제조회사 RA 경력자 우대 -초음파진단시스템 경험자 및 관련 지식 보유자 우대 | 
