3 jobs found in Hong Kong

About the CompanyOur client is a German medical company which focuses on both devices and drugs. They are now looking for a Regional Regulatory Affairs manager for the APAC market. They have over 30 production sites globally to provide products and services for patients with a specific disease. If you are looking for a regional exposure within the medical field, please apply! About the TeamYou will be working in a team of 3 and reporting to the Regional Head of Quality and Regulatory. About the jobAs a Regional Regulatory Affairs Manager, you willobtain product approvals in different APAC countries (e.g. Australia, Malaysia, Singapore, TW, etc.)apply for new product registrations in Germany and APAC countries and make sure it’s complied with local medical devices or drug’s regulations responsible to prepare regulatory materials for MDR, recall and adverse events responsible for medical devices and drug’s complaints regarding to the regulatory issues maintain and develop product licenses in APAC countrieswork cross-functionally in order to provide regulatory input for product development and improvementsupports audit internally and externally draft and review regulatory documentsmaintain and develop SOPs on RA and product safety maintain good relationship with internal and external parties such as distributors, commercial teams and service teamsSkills & Experience requiredbachelor’s Degree in Biomedical engineering or science related aspects at least 4 years of experience as regulatory affairs in Medical device/ Pharmaceuticals sectorexperienced in handling medical devices/ drugs from europe or united state experienced in working across the APAC areas excellent command in oral and written English, Mandarin and Cantonese Candidates without concrete regional experience will also be consideredInterested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at perry.chung@randstad.com.hk for any questions you might have.

About the CompanyOur client is a global leading medical device company which focuses on surgical products including surgical imaging and related accessories. They are one of the market leaders in the field and they have a very strong pipeline in their big business plans as well! They are now looking for a Regulatory & Quality Assurance Manager to support their business and build up the team potentially. This would be a new headcount and new team for the business, you will have great potential to develop your career here with a strong product portfolio. Please apply if you are experienced in medical device RAQA functions. About the TeamReporting to the Head of Regulatory & Quality Assurance. Closely working with the engineering team, Sales & marketing team and external parties. You will manage the whole portfolio of Regulatory & Quality Assurance in Hong Kong. About the jobAs a Regulatory & Quality Assurance Manager, you willmanage the whole product portfolio’s RAQA issues to meet the compliance requirementsensure all required documentation are prepared for the approval process make sure all quality management systems comply with global standards responsible to prepare regulatory materials for MDR, recall and adverse events responsible for medical device complaints regarding to the regulatory issues work closely with regional RAQA teams to implement new product registrations locallywork cross-functionally in order to provide regulatory input for product development and improvementsupports audit internally and externally (ISO 13485, MDSAP, etc.)maintain good relationship with internal and external parties such as distributors, commercial teams and service teamsSkills & Experience requiredbachelor’s Degree in Biomedical engineering or science related aspects at least 6 years of experience as regulatory affairs in medical device sectorexperienced in handling medical devices from europe or united state experienced in working across the APAC areas is advantageous excellent command in oral and written English, Mandarin and Cantonese Interested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at perry.chung@randstad.com.hk for any questions you might have.

about the companyOur client is a global leading pharmaceutical company which focuses on immunology and coagulation drugs. They are now looking for a Regulatory Affairs manager to support their business in Asia Pacific. You will work closely with both commercial and technical teams across APAC areas which include the distributor model as well. You will be working in a very stable working environment with great potential for growth. As a pioneer in the field, they keep investing in R&D, with a great amount of value over the last 10 years, to develop more life-saving therapies for patients and practitioners. Please apply if you are experienced in regional regulatory. about the teamYou will be working in a team of 4 and reporting to the Head of Regulatory Affairs. about the jobAs a Regulatory Affairs Manager, you willResponsible to support regional regulatory tasks for a range of investigational and licensed products Working closely with Regional Regulatory Managers, Scientists or Therapeutic Area Leads primarily on operational activities and projectsSupport the compilation and submission of high-quality documentation such as new license applications, change applications, labeling submissions, license renewals, clinical trial applicationsProvide dossier operational support to the Regional Regulatory Manager or Scientist and Therapeutic Area LeadAssist in reviewing technical and/or scientific information for compliance with regional regulatory requirements and interpretationsGathers and assembles information necessary for submissions in accordance with regulations and relevant guidelinesDraft and review regulatory documentsMaintain good relationship with internal and external parties such as distributors, commercial teams and service teamsskills & experience requiredbachelor’s Degree in science, pharmaceuticals or related fieldat least 4 years of experience as regulatory affairs in pharmaceuticals sectorexperienced in working across the APAC areas excellent command in oral and written English, Mandarin and Cantonese Candidates without concrete regional experience will also be consideredInterested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at perry.chung@randstad.com.hk for any questions you might have.