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job number 1393121
business ge healthcare
business segment healthcare
posted position title regulatory affairs leader
career level experienced
function quality
function segment regulatory affairs
location korea, republic of
city seoul
postal code 135-100
relocation assistance no
role summary/purpose the regulatory affairs leader may be involved in pre or postmarket duties or both.
.act as liaison with external regualtory reviewers to gain rapid approval of submissions.etc, health canada, g. fda, kfda, mhlw.support local regualtory authority / notified body inspections as required
.
3.demonstrated expeirence interfacing with regualtory agecnies (e.
8.prior expeirence using spreadsheet and presentation software.
2.regulatory affiars certification (raps).g. aers and reclals) to the p&l.
6.strong problem solving and negotiation skills
7.
.partner with proudct ra professionals to review advertising and promotion materials for country or regional compliance and approve these as required.
7.demonstrated understanding of healthcare environment and knoweldge of current competitive, commercial or political situations and their impact on gehc regulatory strategies.review field action information to determine if reportable in local country,
?following psrb decision.excellent verbal and written communication and presentation skills with the ability to commuincate business issues in english in an easy to understand manner.demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
.support regulatory compliance and optimization of quailty system procedures relating to new proudct registration submissions through the development, maintenance and improvement of documented processes.as required,
?act as liaison with external regulatory bodies, to ensure appropriate and timely responses are provided to inquiries regarding product reports.coach and mentor other ra professionals
premarket
.
3.proven application of analytical skills in a regulatory environment
4.experience with working across cultures/countries/sites
6.
?provide evidence of official closure of postmarket actions (e.including knowledge & experience applying drug or deivce laws & regulations for product registration, advrese evnet repotring, bachelor\'s degree (or internationally recognized equivalent) & minmium of 3 yeras experience in the medcial device or pharmaecutical indsutry or with medcial product regulatory agecnies; or minimum of 7 years progrsesive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, & reclals
2.
8.experience with adverse event reporting and recalls.
postamrket
.
4.knowledge of quality manaegment sysetms (qms)
5.communicate with product ra resoruces to estalbish regulatory requierments, including clinical trial data.
desired characteristics 1.
qualifications/requirements 1.regulatory,
5.demonstrated knowledge & experience conducting scientific, or business research, legal.technology or legal disciplines, advanced degree in scientific.
?support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.
.work with appropriate product ra representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.
.monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner.reviews new reportable adverse events for country reportability.
?prepare regulatory authority responses to inquiries; work with the p&l to ensure accurate response.he/she provides subject matter expertise and works with a team of ra professionals to ensure gehc establishes best practices in premarket & postmarket for ra, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.create regulatory compliance / project plan with product ra to ensure all requirements are met for country regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
.
9.must be willing to travel up to 10% of time.) and standards bodies such as aami, iso, ul, iec.analyze & communicate changes and proposed changes to country regulations through regulatory intelligence and implement strategies
.plan & evaluate deliverables to established strategic goals, ability to prioritize.
essential responsibilities .
.provide ra support as needed to clinical studies to ensure regulatory requirements are met.localize if applicable,
?prepare recall submissions.& advise company professionals to ensure compliance with regulatory requirements
, train, educate.file / maintain regulatory deliverables
.ability to work well independently & in a team setting.
