Regulatory Affairs Manager-GE Healthcare Korea 경력직

[GE Healthcare 인사담당자]

 

회사소개	기업명 : GE Healthcare KOREA 대표자 : 카림카르티  업종 : 무역업, 도매업
◈ 사업내용   및 회사연혁	GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
◈ 홈페이지	http:// www.gehealthcare.co.kr
◈ 모집분야   (업무내용)	Regulatory Affairs Manager-GE Healthcare Korea 경력직
◈ 모집인원	1명
◈ 고용형태	정규직
◈ 지원자격	Role Summary/Purpose The Regulatory Affairs (RA) Manager may be involved in Pre or Postmarket duties or both. They provide advice & counsel to business managers and Quality & Regulatory personnel within the region. He/she works with a team of Regulatory Affairs professionals and provides subject matter expertise and counsel to ensure GEHC establishes and implements best practice in premarket & postmarket for RA and ensures accurate and optimal presentation of all regulatory reports to meet the requirements  Essential Responsibilities ·File/maintain regulatory deliverables ·Support local regulatory authority / notified body inspections as required. ·Identify regulatory trends and their implications for GE Healthcare; analyze & communicate proposed, new or changing requirements; communicate and track information for country. ·As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility Premarket ·Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions ·Communicate with Product RA to establish regulatory requirements, including clinical trial data. ·If specific country testing is needed, work with Product RA and arrange for test devices and support as needed. ·Provide RA oversight to clinical studies to ensure regulatory requirements are met ·Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required. ·Act as liaison with external regulatory reviewers to ensure appropriate input into regulatory strategy gain rapid approval of submissions. ·Work with Product RA for countries with license expiration requirements to establish plan and deliverables for timely submission for renewal of license. Postmarket ·Liaise with relevant personnel to ensure appropriate, timely input is provided for postmarket reports ·Review and approve new reportable adverse events for region reportability. ·Following PSRB decision, review field action information to determine if reportable in local country. ·Prepare recall submissions, localize if applicable. ·Provide expertise for tactical planning to ensure optimal resources allocation; partner with leaders within RA to implement strategies and drive RA initiatives. ·Review and submit Regulatory Authority responses to inquiries. ·Update the appropriate resources on reporting status and feedback from regulators. ·Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L. ·Liaise with country/regional regulators regarding current or past postmarket reports; respond to requests for information from regulators.  Qualifications/Requirements 1.Bachelor’s Degree (or internationally recognized equivalent) & minimum of 7 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 11 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations. 2.Demonstrated experience operating in a highly regulated environment; proven application of analytical skills in a regulatory environment 3.Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc. 4.Demonstrated project management skills; ability to prioritize, plan, eval‎uate & execute deliverables for established tactical goals 5.Demonstrated ability to lead cross-functional, cross-business teams 6.Ability to influence and make recommendations at multiple levels of the company. 7.Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements. 8.Experience using spreadsheet and presentation software 9.Must be willing to travel up to 15% of time. Desired Characteristics 1.Advanced degree in scientific, technology or legal disciplines. 2.Regulatory Affairs Certification (RAPS). 3.Knowledge of Quality Management Systems (QMS). 4.Experience working across cultures/countries/sites. 5.Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 6.Strong problem solving and negotiation skills. 7.Demonstrated ability to work well independently & in a team setting. 8.Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively. 9.Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
◈ 접수기간	09년 09월 30일 23시- 내방문의 사절
◈ 접수방법	Please upload your Resume with Coverletter GE Career Site.     http://www.ge.com/kr/careers/index.html  (19. Regulatory Affairs Specialist, Product - GE Technology Infrastructure, Healthcare )
◈ 전형절차	전형절차 : 서류전형→면접전형→최종합격 발표방법 : 개별공고, 면접 일정은 합격자에 한해 개별 통보
◈ 제출서류	영문 자기소개서 및 이력서 제출
◈ 근 무 지	서울 청담동 71-3 지이타워
◈ 급여조건	면접 후 결정
◈ 복리후생	월차, 연차, 건강보험, 4대보험, 휴양시설지원, 자녀 학자금지원, 동호회지원
◈ 인사담당자   문의처