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- Á¢¼ö¹æ¹ý : ÀÚÀ¯¾ç½ÄÀÇ ¿µ¹®À̷¼, ÀÚ±â¼Ò°³¼¸¦ ÇϳªÀÇ ÆÄÀÏ·Î À̸ÞÀÏ Á¢¼ö (°¢Á¾ Áõºù¼·ù´Â ¼·ùÀüÇüÇÕ°ÝÀÚ¿¡ ÇÑÇØ ÃßÈÄÁ¦Ãâ) À̸ÞÀÏ ÁÖ¼Ò ¹× ¿¬¶ôó ±âÀç (À̸ÞÀÏ Á¦¸ñ : Application to 2020 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 strategy2. 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 objectives6. 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/position2. Complete all planned Quality & Compliance training within the defined deadlines3. Identify and report any quality or compliance concerns and take immediate corrective action as required4. 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 responsibility6. 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 environment4. 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 manner6. Prior experience using spreadsheet and presentation software7. 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.
±âŸȸ»ç ¼Ò°³ÀÚ·á ¹× 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)
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003