ORT Uruguay University

Advanced Biomedical Instrumentation Centre Limited (“ABIC”) is a collaborative effort coordinated by the University of Hong Kong (HKU) undertaking R&D projects at the Hong Kong Science and Technology Park (HKSTP). The aim of the Centre is to develop and commercialise new and disruptive biomedical instrumentation that will meet the growing needs in medicine and contribute sustainably to human health, and drive the economic growth of Hong Kong through commercialisation. Applications are invited for appointment as Senior Clinical & Regulatory Affairs Specialist (Ref. H01/2026/053). Job Description Study biomedical technologies and products, and investigate pre-clinical and clinical approval strategies at the US FDA, China NMPA, Japan PMDA, European EMA, Australia TGA, and other regulatory bodies. Coverage includes medical devices, drugs, and medical computer software, including AI tools and data science applications. Develop detailed plans for obtaining regulatory approval, from conducting pre-clinical studies for clinical trial entry, to running and completing clinical trials required for market authorisation. Draft, explain, negotiate, and deliver high-quality presentations of regulatory plans to investors, companies, regulatory bodies, medical doctors, CROs, CDMOs, and other relevant stakeholders. Act as the primary contact point for regulatory officers, medical professionals, investors, company representatives, research teams, consultants, and manufacturers. Represent ABIC in various meetings and produce all necessary written materials to drive projects forward through effective communication. Manage projects by calculating and tracking budgets and expenses, and closely follow up on project milestones to ensure they are executed according to schedule, without delays or budget overruns. Identify and recruit clinical doctors, hospitals, and clinical groups to participate in clinical studies. Deliver presentations and negotiate with these parties to secure their support for clinical projects, ensuring they meet the needs and requirements of both ABIC and investors. Scope of work includes both Investigator-Initiated Trials (IIT) and sponsored trials, and also pre-clinical operations. Demonstrate a comprehensive understanding of conducting clinical studies and serve as the primary author for relevant documentation, including clinical protocols, informed consent forms, collaboration agreements, Institutional Review Board (IRB) submission packs, and progress reports. In addition to drafting documents, effectively deliver oral presentations as required. Serve as the primary point of contact to support and liaise with clinical doctors, nurses, laboratory operators, and logistics personnel, ensuring the smooth daily operation of projects. For pre-clinical development, develop, monitor, and track in-vitro, in-vivo (animal), and data science studies to ensure valid planning and adequate progress towards securing approval from pre-clinical to clinical stages. For manufacturing, act as the primary person to source, screen, negotiate contracts with, and monitor the progress of CDMOs or internal manufacturing teams. Ensure products and prototypes are adequately prepared to facilitate the commencement of clinical studies and obtain approval for human trials. Develop and execute plans in collaboration with relevant teams to create Drug Development Tools (DDT), New Approach Methodologies (NAMs), ISTAND qualifications, organ-on-chip models, in silico analyses, and other methodologies intended for qualification by the FDA or other regulatory bodies. Develop and manage Quality Management Systems (QMS) for biomedical product development. Travel as needed for meetings and work-related duties, under the instruction of ABIC supervisors. Frequent travel to the Chinese Mainland and other overseas regions is expected. Actively participate in commercialisation activities, including identifying and engaging with investors who support biomedical projects. Conduct business pitches, prepare business financial projections, draft agreements, and proactively seek and negotiate business partnerships. Play a core role in pitching to stakeholders across both the commercial and government sectors, including investment funds, corporate entities, government units, and science parks. Seek business operations and investment opportunities. Act as a proactive, outgoing, and communicative negotiator capable of sourcing and engaging with both scientific and commercial (non-scientific) individuals and organisations. Build and maintain strong, trusting relationships with external parties to benefit both the scientific and commercial objectives of the business. Share knowledge with, educate, and train both internal and external teams on topics including pre-clinical and clinical studies, qualification and approval processes, and CDMO/CRO management. Work flexibly to meet project milestones and coordinate effectively within a team under the supervision of senior staff members of the Centre. Perform any other tasks specified by your supervisor that are not mentioned above. As ABIC is not a large-scale organisation, you will be expected to undertake a variety of new tasks as required by your supervisor. There are no rigid boundaries to your job scope. Your scope of work is not fixed, and will change when instructed by your supervisor. You must remain flexible regarding your job scope when requested by your supervisor. Skills and Requirements PhD degree in Healthcare, Life Sciences, or a related discipline from a university (with the specific subject area ranked within the world’s top 100) At least 5 years of experience in running pre-clinical operations, and also clinical studies through hospital IRBs and securing regulatory approvals from FDA, NMPA, EMA and/or PMDA. In-depth knowledge of regulatory approval processes and requirements for medical devices and/or biologics across key markets. Ability to deliver excellent presentations to investors and business partners. Highly outgoing and extroverted personality; very skilled at building networks and relationships with new partners for both commercial and research operations. Speaks excellent English and Putonghua; able to write professionally in Chinese and English with high-quality output. Proven experience in writing, submitting, and managing regulatory dossiers, including pre-submission meetings and responding to authority queries. Corporate R&D hands-on experience is a MUST. Ability to quickly learn and acquire highly sophisticated scientific and business knowledge (not just scientific or business alone, but both). Capability to independently run projects without close supervision or guidance. Highly ambitious and very hardworking (this is not a standard 9:00 a.m.–6:00 p.m. job). Willing to work outside normal office hours and on weekends. Willing to undertake frequent travels (to both Chinese Mainland and overseas) when requested.  A salary commensurate with qualifications and experience will be offered. Applicants should submit their up-to-date C.V., quoting the job reference number, with information of current/expected remuneration and availability, to mandy.tse@abic.hk. The review of applications will commence as soon as possible and continue until the posts are filled. The personal data provided in your application process will be used for recruitment and other employment-related purpose. The personal data may be transferred and disclosed to, and used by HKU Innovation Holdings Limited and The University of Hong Kong for the above purposes. We are an equal opportunities employer and welcome applications from all qualified candidates.

The University of Surrey is a global community of ideas and people, dedicated to life-changing education and research. We are ambitious and have a bold vision - shaping ourselves into one of the best universities in the world - which we are achieving through the talents and endeavour of every employee. Our high-achieving Advancement team recently closed its first global campaign, and is now building on this success to drive even greater philanthropic impact. Our high-achieving Advancement team recently closed its first global fundraising campaign, and is now building on this success to drive even greater philanthropic impact. The Advancement team of 25 ambitious professionals work with our global community of 153,000 alumni in 185 countries delivering alumni engagement activities and securing donations to support research and students at the University. The role We are seeking an outstanding assistant to provide high-quality, professional administrative and PA support to the Director of Advancement and the Advancement Leadership Team. This is a key role for an organised, proactive and personable individual who takes pride in delivering a seamless service, enabling senior leaders to operate effectively and efficiently within an ambitious Advancement function. The University operates a hybrid working approach and this role will be a minimum of three days per week office-based with flexibility to attend campus more frequently when required. Part-time hours will be considered for the right candidate. About you If you are highly efficient, dependable and trustworthy, with excellent administrative skills and a naturally warm and professional manner, we would welcome your application. You will join a friendly and forward-looking team at the University of Surrey, working in a collaborative environment and contributing to work that directly supports students, research and the University’s global ambitions.  How to apply To apply, please upload a CV and cover letter outlining why you would be a suitable candidate for the role. Previous applicants need not apply. The University of Surrey reserves the right to close this vacancy early based on volume and calibre of applications. If you would like to discuss the role further, please contact Michelle Cruickshank, Senior Alumni Relations Manager m.cruickshank@surrey.ac.uk for an informal chat. In return we offer a generous pension, flexible working options including job share and blended home/campus working locations (dependent on work duties), access to world-class leisure facilities on campus, a range of travel schemes and supportive family friendly benefits including an excellent on-site nursery. Click here to find out more about the benefits we offer to support you. The University of Surrey is committed to providing an inclusive environment that offers equal opportunities for all. We place great value on diversity and are seeking to increase the diversity within our community. Therefore we particularly encourage applications from under-represented groups, such as people from Black, Asian and minority ethnic groups and people with disabilities. Further details Job Description

The Role and Department The Department's undergraduate curriculum is notable for its historical and cultural breadth, combining compulsory modules in Theory, Shakespeare and an independent Dissertation, with a range of period-based modules taught by lectures and tutorials, and research-led special topic semininars. There are thriving MA programmes in English Literary Studies and in Creative Writing, and a lively community of PhD students. Applications are invited for a Teaching Fellow in Early Modern Literature. This is a 1.0 FTE position for 12 months only. The successful applicant will: Teach undergraduate tutorials in Introduction to Drama (Level 1) and seminars on John Milton (Level 2). Potentially contribute to Renaissance Literature and/or Shakespeare. Deliver lectures as required in these areas. Supervise Level 3 undergraduate dissertations. Potentially supervise MA theses. Contribute to lively and stimulating small group teaching, in person. Undertake assessment and examination of UG and MA student work, in and beyond Early Modern Literature. Act as an Academic Advisor to a group of UG students. Participate in the meetings of the Department as appropriate. Pursue opportunities for personal development. The post-holder will report to the Head of Department. Career development opportunities will be offered. Teaching Fellowships offer the opportunity of valuable experience to those early in their academic careers and the University is keen to maximise the benefit to as many people as possible.The post of Teaching Fellow will involve a significant teaching load, which may extend into the summer period, and there may be related scholarship and the opportunity for administrative duties which relate to education and pedagogy. The post is for a fixed term only, and it is not anticipated that the post will be extended beyond this fixed term. Successful applicants will, ideally be in post by 1 September 2026 . The University provides a working and teaching environment that is inclusive and welcoming and where everyone is treated fairly with dignity and respect. Candidates will be expected to demonstrate these key principles as part of the assessment process.