Cham, Zug, Switzerland
A self-motivated, problem solving professional, with 11 years of clinical experience, now utilising my communication, organisational and leadership skillset as an Agile qualified, Project Manager in the medical device industry.
- Owned the end-to-end product lifecycle for Hocoma’s lower extremity rehabilitation portfolio, from concept and market evaluation through launch, optimisation, and end-of-life management. -Defined clear value propositions and business plans based on market insights, competitive intelligence, and customer needs across global neuro-rehabilitation markets. -Optimised the lower limb product portfolio by developing segment-specific offerings and translating continuous market feedback into actionable innovation roadmaps. -Led product-specific go-to-market strategies, collaborating cross-functionally with marketing, sales, R&D, clinical, and regional teams to drive successful international launches. -Delivered product training, market insights, and sales enablement materials to empower regional sales teams and improve commercial performance. -Ensured Regulatory Affairs (RA) and Quality Assurance (QA) compliance, monitoring quality topics to meet evolving medical device regulations and documentation requirements. -Supported clinical evaluations, user feedback programs, and usability validation to ensure strong clinical relevance and real-world performance. -Contributed to key product documentation, including technical files, instructions for use (IFUs), and clinical documentation. -Supported forecasting, inventory planning, and component end-of-life management, aligning product availability with market demand. -Represented Product Management in external partner meetings, customer visits, and cross-organisational initiatives, building trusted long-term relationships.
- Project managed New Product registrations, Renewals and deficiency based activities of class 1-3 medical devices in Trauma and Extremities division in-line with country specific requirements. This entailed having a strong knowledge of FDA 510K, EU MDD/MDR, MDSAP regulations and ISO 13485 standards. - Managed the project scheduling, planning, risks, budget and deliverables within the International Regulatory Affairs team utilising Microsoft Project, Teams, Excel and PowerBI skillset. This included the China Due Diligence project. A Key project to maintain and grow Chinese Market share. - Worked alongside SME’s (Clinical, Medical, Labelling) and R&D teams to maintain product registration with National Health Authorities requirements (NMPA, TGA, MDA, HSA, TFDA, MedSafe). - Reported on a weekly, monthly and quarterly basis to senior leadership/project sponsors on progress whilst escalating risk as soon as possible with a comprehensive, actionable plan. Develop robust regulatory strategies to capture International requirements which enabled quickest route to market to enhance market share within the Orthopaedic medical device market. - Developed and maintained a Country Requirements and Country of Origin (COO) Matrix/database to support New Product development and R&D sustaining teams to ensure International requirements were capture to increase speed to market and reduce COO deficient related questions. - Responsible for obtaining Free Sales Certificates and Certificates of Foreign Government for the T&E portfolio as well as supporting technical documentation updates inline with any engineering changes. - Developed and updated internal Standard operating procedures within international RA and support internal and external audit activities.
-Responsible for the implementation, delivery and maintenance of referral optimisation strategies (video consultation, patient initiated follow up and specialist advice) across the 1.1million residents of Surrey Heartlands, UK, aligning with the national NHS and local objectives to reduce outpatient attendances in hospitals. -Defined current processes and status of work for multiple health pathway interventions and coordinated both service development and redesign of existing programmes to provide better outcomes for patients, clinicians and local systems. -An integral part of the role is the facilitation of discussions with key stakeholders to ensure collaborative working and sharing key learnings and best practice. -Other activities include organising virtual workshops to help this knowledge sharing and allow conversations from concept through to procurement to deliver pathway changes and savings associated with them. -Budget planning for project costings is a main responsibility to ensure initiatives are delivered within budget allocation and requires multi-disciplinary working with the finance team. -Report writing, presentations and formulation of business cases with risk management are essential to the delivery of the Outpatient Transformation Programme.
-Managed a complex clinical caseload of patients with persistent Musculoskeletal conditions with complex challenging clinical presentations. -Close collaborative working with clinical stakeholders (consultants, psychologist, nurses) to design and implement a six week educational course for managing persistent low back pain which included psychological, social and physical wellbeing themes to reinforce long term healthy behaviours in keeping with NHS, N.I.C.E and W.H.O guidance. This was evaluated using outcomes measures. -Completed weekly and monthly performance reports on progress of departmental KPI’s. -Led recruitment of multiple members of staff across a wide variety of seniority, in line with NHS policy and procedure. -Managed day to day running of the Physiotherapy department which included complaints, staff illness and local estate concerns.
-Worked in a busy private Physiotherapy clinic in Surrey, UK managing a complex clinical caseload of Musculoskeletal conditions. -A key component of the role was building and maintaining strong, professional working relationships with local Orthopaedic, Sporting, spinal and pain Consultants which was at the foundation of all patient referrals -The role also included presenting educational talks to the local community, data collection of patient outcome measures and reporting to private insurers with patient progress and networking with clinicians. -Personal development included multiple Physiotherapy CPD events and courses