Regulatory Affairs Specialist

3 дней назад

Киев, Киев, Украина Roche Полный рабочий день

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Affiliate: Roche Diagnostics Korea

Division : Regulatory & Quality

Work location: Seoul, South Korea

Roles & Responsibilities

  • Regulatory Strategy & Submissions: Develop and execute regulatory strategies for timely market access in Korea, leading the preparation and submission of high-quality dossiers to the MFDS.

  • Ensure timely submissions and approvals by preparing high-quality regulatory applications in line with planned or committed timelines.

  • Regulatory Intelligence & Communication: Monitor the Korean regulatory landscape, interpret new regulations, and serve as the primary communication contact with the MFDS.

  • Cross-Functional Collaboration: Act as the RA expert on project teams, collaborating effectively with global, APAC & local stakeholders (Medical Affairs, Clinical Operations, QA, Marketing) to ensure regulatory strategy alignment.

  • Apply expert knowledge of clinical performance evaluation in compliance with ISO 20916 and MFDS regulations.

  • Maintain substantial knowledge of principles and scientific theories, contributing to scientific validity and clinical utility where applicable.

Qualifications

  • Experience & Education: Bachelor's degree or higher in a relevant scientific field with a minimum of 7 years of RA experience in the Korean medical device/IVD industry.

  • Regulatory Expertise: Expert knowledge of MFDS MD/IVD/Digital Medical Product regulations. Experience with IVD / SaMD registration and clinical performance studies is highly preferred.

  • Core Competencies: Strong strategic thinking and problem-solving skills with a collaborative mindset.

  • Language Proficiency: Exceptional written and verbal communication skills in both Korean and English.

Submission

자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출)

※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.

※ 이력서 내 이메일 주소와 서류전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다. 

※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다.

※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오.

※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다.

Process

서류 전형 면접 전형 종합 심사 최종 합격 통지

※ 면접은 서류전형 합격자에 한해 개별 통보합니다.

※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.

※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

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