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Overseas Regulatory Affairs Manager

QA & RA Team

We’re looking for individuals with deep understanding in medical devices and related regulations, and effective communications skills. The Quality Assurance & Regulatory Affairs team is involved in every process of the product development. The team identifies the users’ needs and related regulatory guidelines, verifies the safety and efficacy of the medical device products, and oversees the release and distribution processes in the market. 

RA팀은 의료기기 개발 전주기에 개입하며 고객의 요구 및 관련 법령을 파악하고, 의료기기를 시장에 출시하기 전 제품의 안전성과 유효성을 증명하는 일을 합니다. RA팀은 의료기기 제품과 규정에 대한 이해력, 원활한 의사소통을 위한 논리력을 갖춘 인재를 찾고 있습니다! 

Job Description
  • Generate/present analysis and requests for foreign regulatory related guidances including FDA
  • Research on market trends and stay up to date on the latest regulatory approvals for overseas competitors
  • Manage CRO for foreign regulatory approval process and prepare necessary documentations
  • Prepare foreign regulatory approval related documentations and perform all related communications
  • FDA를 비롯한 해외 인허가 관련 가이던스 분석 및 요구사항 도출/전파
  • 해외 경쟁사 동향 파악 및 조사
  • 해외 인허가 CRO 관리 및 문서 작성
  • 해외 인허가 관련 문서 작성 및 인허가 관련 커뮤니케이션 수행
Qualifications
  • 3+ years of experience in foreign regulatory affairs
  • 해외 인허가 관련 3년 이상 경력
Preferred
Qualifications
  • Experience with FDA approval for IVD medical devices
  • BS degree or above in Life Science related fields
  • FDA IVD 인허가 진행 경험
  • 생명과학계열 전공
Benefits
Flextime
We have flexible working hours to accommodate our employees’ individual needs and other commitments outside of work!
Welcome kit

We offer office supplies, equipment, devices, etc. (of your choice) that you will need in order to get you started!

Meals on us

Lunch and dinners are on us, whether or not you work overtime! Our office pantry is always stocked with coffee, soft drinks, ramen and snacks!

Growing together

You are welcome to take all conferences and sessions that you may find relevant. Purchases towards books and lectures that you may find useful to your growth are also funded.

Refresh

Every year, we have holidays from the Christmas day to second day of January to relax and revitalize!

Health and safety come first

We encourage our employees to work from home during the COVID-19 pandemic, and paid leaves for vaccinations are provided.

Your family is our family

We provide allowances for family related celebrations or condolences. You can also apply for Asset Building Program for Youth Employee (청년내일채움공제)

Flextime

코어타임 운영과 자유로운 휴가신청!

11시 ~ 15시 Core time 제도 자율 출퇴근 제도를 운영합니다. (주 40시간 선택근로제)

Welcome kit

업무에 필요한 물품 구매를 지원합니다.

Meals on us

점심, 저녁은 회사가 쏩니다! 야근 여부 상관없이 저녁 식사비를 지원해요.

커피와 간식도 항상 구비돼 있어요.

Growing together

업무에 필요한 직무 관련 콘퍼런스 및 외부 교육은 물론, 원하는 도서나 개발 강의까지, 요청만 하면 모두 지원합니다.

Refresh

매년 연말이 되면 크리마스부터 새해까지 특별 휴식기간으로 모두 함께 쉬는 시간을 가집니다.

Health and safety come first

코로나로 인한 재택 근무와 백신휴가 제도를 적극 권장하고 있어요.

Your family is our family

경조사 휴가 및 경조비를 지급합니다. '청년내일채움공제' 신청도 가능해요.

Interested in this position?
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letter to recruit@deepbio.co.kr

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