Save JobEmail Job Back to Search Job Description Summary Similar JobsLeadership RoleCompetitive remuneration packagesAbout Our ClientOur client is an well-established medical device company, aiming to improve the health of patients across the world through their high quality medical device.Job DescriptionManage the Regulatory Affairs departments ensuring resources and expertise are assigned to meet company goals, objectives and regulatory compliance. Provide ongoing coaching and feedback to develop the team for future Regulatory Affairs leadership in the regionEnsure personal and team compliance, QMS procedures, policies and relevant medical device standards and regulationsProvide expert opinions on technical and legal matters associated with the registration of products in the region to internal stakeholdersLiaise and collaborate with various stakeholders in relation to all regulatory issuesFacilitate communications between all stakeholders in order to get products registered in the regionLiaise with all relevant distributors worldwide to ensure information flow and understanding of current processesCollaborate with regional leadership to support APAC focused business improvement activitiesEnsure timely and accurate reporting of key performance indicators in support of the regulatory metricsMaintain an excellent understanding of all medical device regulatory requirementsEnsure all quality, regulatory, compliance, and product-specific requirements are metPerform any ad hoc duties as requiredThe Successful ApplicantBachelor Degree in life science related disciplines10+ years of RA experience in Medical Device industryExperience with the regulatory environments of other Asian markets is preferredAllocates time and resources effectively and efficiently to achieve agreed outcomeWell-organised, Ability to work under pressureExcellent verbal and written English and Chinese communications skillsWhat's on OfferA competitive remuneration package will be given to the right candidate.ContactZalika HoQuote job refJN-052022-5630324Phone number+852 2848 4783Job summaryFunctionLife SciencesSpecialisationRegulatory AffairsIndustryHealthcare / PharmaceuticalLocationHong KongJob Type:PermanentConsultant nameZalika HoConsultant phone+852 2848 4783Job ReferenceJN-052022-5630324
