[한국벡크만쿨터] RA SR. SPECIALIST 경력직 채용

열정이 있는 여러분의 많은 지원을 기다리고 있습니다.

벡크만쿨터(Beckman Coulter)는 지난 80년 동안 전세계 의료 전문 인력들의 신뢰할 수 있는 파트너로서

혁신적이고 효율적인 연구 및 진단 솔루션을 제공하여 과학과 의료 분야를 발전시키고 있습니다.

지난 2011년에는 다국적 헬스케어 기업인 다나허(Danaher)에 인수되면서 진단 업계에서의 선도적 지위를 강화했습니다.

벡크만쿨터의 장비는 질병을 진단하고 치료에 대한 결정을 내릴 수 있도록 환자를 모니터하기 위한 용도로 생산되어

전세계 병원의 진료 환경을 개선시키는데 도움을 드리고 있습니다.

이에 벡크만쿨터와 미래를 함께할 열정이 있는 우수한 인재의 지원을 기다리고 있습니다.

(FY17 매출액 : 58억불, 직원수: 11,000명~, 본사 : 미 캘리포니아 브레아)

접수기간 및 방법

- 접수기간 : 2021년 4월 12일~ (수시 채용)

- 접수방법 : korea-recruiting@beckman.com으로 영문이력서/자기소개서를 하나의 파일로 접수 (자유양식)
                이메일 주소 및 연락처 기재 (이메일 제목 : Application to 2021 Sr. RA Specialist Position)


Description:

The RA Sr. Specialist provides subject matter expertise and works with a team of regulatory affairs professionals to ensure Beckman Coulter establishes best practice within the assigned area of responsibility (country regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, QMS, and etc).

Key responsibilities include:

1. Lead the preparation of premarket submission documents & smart registration strategy
2. Lead the tactical product registration of Immunoassay, Clinical chemistry, Hematology, Microbiology, etc. by communicating directly with a global RAs, regulatory agencies, and so on. 
3. Maintain KGMP certificate new/renewal by cooperating with global manufacturer QRAs & R&D for business continuity.
4. Work closely with country/BU regulatory, marketing, CAS, SVC and other professionals across the company to develop & implement company-wide programs and processes for QARA compliance within areas of responsibility.
5. Identify regulatory trends and their implications for Beckman Coulter; Develop & implement effective regulatory strategies to meet business objectives
6. Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility, and to communicate with global RI channel to deliver the change of regulatory environment to input the design change process.
7. Educate, train, & advise company professionals to ensure compliance with RA requirements.
8. Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
9. Develop QRA performance KPI metrics to identify program weaknesses & drive improvements in procedures or oversight.
10. Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility.

Quality Specific Goals:

1. Aware of and comply with the BEC/BCK Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
5. Effectively support implementation & management of current regulatory requirements within area of responsibility
6. Ensure assigned regulatory submissions are accurate, complete and timely

Qualifications:

1. Bachelor’s Degree & minimum of 5 years or over experience in the IVD, medical device, or pharmaceutical industry or government / government relations; OR minimum of 7~10 years progressive regulatory affairs experience in medical device or pharmaceutical industry or government / government relations, including knowledge & experience applying global drug or device laws & regulations for product registration, adverse event reporting, & recalls.
2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.
3. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
4. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
5. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
6. Prior experience using spreadsheet and presentation software
7. Must be willing to travel up to 30% of time for a business trip abroad.

Preferred Qualifications:

1. Advanced degree in LS, chemistry, scientific, technology or legal disciplines etc.
2. Regulatory Affairs Certification (RAPS).
3. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, MFDS, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
4. Knowledge of Quality Management Systems (QMS)
5. Ability to work across cultures/countries/sites
6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
7. Strong problem solving and negotiation skills
8. Ability to work well independently & in a team setting.                                                       
9. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on BEC/BCK regulatory strategies.

기타회사 소개자료 및 Website

- Beckman Coulter Homepage : http://www.beckmancoulter.com

- Beckman Coulter Recruiting Homepage : https://www.danahercareers.com/en-US/page/beckman-coulter

- Youtube : “Advancing Healthcare for Every Person”(https://www.youtube.com/watch?v=Fh8yvQ9lBL8)

                 “Working at Beckman Coulter”(https://www.youtube.com/watch?v=TpLgpL57jUE)