* 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, marketing and sales staff as needed* Market analysis: monitoring competitors' activities & product offerings* Driving revenue… Show more * 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, marketing and sales staff as needed* Market analysis: monitoring competitors' activities & product offerings* Driving revenue with existing EU partner hospital (Germany) and tracking sales performance* Managing customer satisfaction with partner hospital and triaging the internal product iteration process based on customer feedback as needed* Working with the production team to optimize COGs and maximize profitability* Working with the CEO of manage the quarterly P&L and forecast of the product line Show less

* 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 evaluation, development, and deployment of all technical and clinical services* Oversee and manage processes relating to clinical… Show more * 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 evaluation, development, and deployment of all technical and clinical services* Oversee and manage processes relating to clinical support, and training of product specialists* Advising the Company regarding scientific matters & identifying new research opportunities* Leading and coordinating research activities Show less

★ 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 and ISO 14155 compliant study protocol⭒ Strategic identification and recruitment of suitable study sites⭒ Liaising with the… Show more ★ 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 and ISO 14155 compliant study protocol⭒ Strategic identification and recruitment of suitable study sites⭒ Liaising with the Clinical Trials Unit/Manager at each site to negotiate trial budgets, indemnity, and governance/HREC approvals⭒ Ensuring all Sponsor responsibilities are fulfilled as per ICH/GCP and ISO 14155 requirements⭒ Managing and conducting Site initiation Visits and Site Activation Show less

★ 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⭒ Developing and leading a small team of engineers carrying out in-depth design and user risk analyses and manufacturing FMEAs⭒… Show more ★ 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⭒ Developing and leading a small team of engineers carrying out in-depth design and user risk analyses and manufacturing FMEAs⭒ Conducting performance reviews⭒ Being heavily involved in the device design and development, prototyping, and V&V stages until design transfer⭒ Planning and overseeing all V&V activities including biological evaluation (ISO 10993)⭒ Writing the Clinical Evaluation Report ⭒ Developing and submitting the Technical File to the NB⭒ Closing out all non-conformities raised by the NB to achieve regulatory approval (CE followed by TGA) Show less

★ 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 of QC measures with suppliers⭒ Managing prototype development, verification, design transfer, and all V&V activities⭒… Show more ★ 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 of QC measures with suppliers⭒ Managing prototype development, verification, design transfer, and all V&V activities⭒ Primary author of Technical File and successful Conformity Assessment with the TGA to achieve regulatory approval Show less

★ 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 requirements⭒ Developing the essential documentation for the Trial Master File (protocol, investigator's brochure, PICF etc.)⭒ Convening… Show more ★ 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 requirements⭒ Developing the essential documentation for the Trial Master File (protocol, investigator's brochure, PICF etc.)⭒ Convening multidisciplinary steering committee meetings to provide study updates/progess⭒ Regularly reporting to the institutional HREC serious adverse events, protocol deviations, and protocol modifications⭒ Being the product specialist during the surgical procedures⭒ Data analysis, write up of study close out reports, and publishing results⭒ Successfully winning the company's first NSW Health Medical Device Fund Grant (2015, $1.75M) Show less

★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 Medical Devices)⭒ A top-down restructuring the QMS using my in-depth and independently gained understanding of higher level standards (i.e.… Show more ★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 Medical Devices)⭒ A top-down restructuring the QMS using my in-depth and independently gained understanding of higher level standards (i.e. ISO 13485, ISO 14971, ISO 14630, MEDDEV 2.12-1)⭒ End-to-end management and execution of a sterilisation validation project of an existing Class IIb implantable device⭒ Facilitating and closing out all non-conformities for 3 TGA audits while increasing the QMS' compliance rating with each audit⭒ Successfully employing a Junior QA Associate and mentoring/training them to replace my role as QA Manager within 6 months Show less

★ 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 personnel ⭒ Contract negotiations and management of suppliers (cleanroom, gamma sterilisation etc.)⭒ Design and development of… Show more ★ 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 personnel ⭒ Contract negotiations and management of suppliers (cleanroom, gamma sterilisation etc.)⭒ Design and development of critical production jigs Show less

★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 follow-ups as per the trial protocol⭒ Regularly briefing and reporting to the Sponsor, Steering Committee of clinicians, and… Show more ★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 follow-ups as per the trial protocol⭒ Regularly briefing and reporting to the Sponsor, Steering Committee of clinicians, and the institutional HREC on various aspects (study progress, adverse events, and other data points)⭒ Facilitating site visits for the Trial Monitor to assist with data verification⭒ Data analysis and write up of study close out reports Show less

★ 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

★ 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 manufacturing SOPs for the production team⭒ Application of risk management procedures (design + manufacturing risks) as per the… Show more ★ 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 manufacturing SOPs for the production team⭒ Application of risk management procedures (design + manufacturing risks) as per the requirements of ISO 14971 Show less