Nyan Khin Email & Phone Number

Sydney, NSW, AU

* EU product roadmap strategy (Turkey, France, Belgium, Netherlands)* Developing launch timeline, building relationships with product champions, prioritisation of milestones, and facilitating a proctoring program for onboarding new surgeons* Establishing effective product distribution channels * Resource management: triaging clinical support staff.

Sydney, Australia

* Scientific and clinical liaison during a successful capital raise ($5M)* Key contributor for a second successful NSW Health Medical Device Fund (2020) grant ($2.4M)* Working with the Board and Executive team to set the company’s technical vision and leading company’s technological development* Developing strategic plans and setting timelines for.

★ Project: Phase Ib/II multi-centre medical device trial in interventional oncology. Reporting to the Sponsor's Managing Director and Board of Directors, I have been responsible for:⭒ Establishing a multidisciplinary team of key opinion leaders in oncology, interventional radiology, vascular and hepatobiliary surgery to collaboratively develop an ICH/GCP.

★ Project: development of a new implantable Class IIa device. Reporting to the General Manager, Managing Director, and Board of Directors, I was responsible for:⭒ Project scoping, planning, and budgeting⭒ Mapping out the regulatory pathway and liaising with the Notified Body (EU) ⭒ Negotiating contracts, managing mutiple OEMs and critical suppliers⭒.

Sydney, Australia

★ Key Project: development of a new Class IIa externally communicating device. Reporting to the General Manager, Managing Director, and Board of Directors, I was responsible for:⭒ Scoping the project and developing a project budget and timeline with critical milestones⭒Mentoring and managing two project engineers ⭒ Contract negotiations and implementation.

★ Project: Medical device safety/feasibility pilot study in interventional oncology. Reporting to the Investigator Sponsor and institutional HREC, I was responsible for:⭒ Establishing a multi-disciplinary team of clinical investigators (oncologists, interventional radiologists, vascular surgeons) to write a trial protocol compliant with ICH/GCP.

★Key Project: Overhaul and streamlining of existing QMS as well as ongoing maintenance for continuous improvement. Reporting to the General Manager, I was responsible for:⭒ Independently and deeply familiarizing myself with the Australian and EU regulatory framework (Aus Therapeutic Goods [Medical Devices] Regulations 2002 and Directive 93/42/EEC on.

★ Key Project: transferring of manufacturing of a Class IIb device in-house from sub-contractor. Reporting to the General Manager, I was responsible for:⭒ Carrying out an initial manufacturing risk analysis and pre-emptively implementing controls to minimise all critical risks⭒ Revising all manufacturing SOPs, training and supervising all production.

★Project: implantable medical device trial for vascular surgery. Reporting to the R&D Manager, Sponsor, and institutional HREC, I was responsible for:⭒ Familiarizing myself with and working within the confines of GCP⭒ Data collection onto source documents and transcription onto CRFs⭒ Managing patient logistics, and attending surgeries, daily visits, and.

★ Key Project: design transfer and V&V of a new Class IIb implantable vascular product. Reporting to the Principal Engineer, I was responsible for:⭒ Developing a V&V plan⭒ Designing and building production jigs, V&V testing setups⭒ Production line optimisation⭒ Executing and tracking progress of planned V&V tests

Sydney, Australia

★ Key Project: Design and development of a new Class IIb implantable vascular product. Reporting to the R&D Manger and the General Manager, I was responsible for:⭒ Designing and developing a prototype device to fulfil the customer brief using CAD (SolidEdge ST)⭒ Design for manufacture using LIM⭒ Familiarizing and applying GMP principles to write.

Honorary Fellow, Department Of Biomedical Engineering

Doctor Of Philosophy - Phd, Department Of Clinical Medicine, Faculty Of Medicine And Health Sciences

The Role of a Universal Vascular Access System in Locoregional Chemotherapy for Solid Tumours

Bachelor Of Engineering - Be, Mechanical Engineering

Study abroad year

Bachelor Of Engineering - Be (Hons), Mechanical/Biomedical