Alan West Email & Phone Number

Kloten, Zürich, Schweiz

Winterthur, Zurich, Switzerland

• Leading EU MDR submission of implantable medical devices to the notified body and management of question rounds• Management of technical documentation for EU classes I, IIa and IIb Orthopaedic products• Evaluation of product and process changes to assess their impact on regulatory compliance• Support risk management, post-market surveillance and clinical activities• Monitor and assess standards, regulations and guidance documents• Management of Regulatory tasks involved with New Product Development with Strategic Alliance partners

Winterthur, Zürich, Schweiz

• Managed registration processes and led submissions in assigned distributor markets.• Aligned with marketing and management to determine commercial priorities and strategy.• Co-ordinated registration requests and change notifications for external alliance companies.

Winterthur Area, Switzerland

• Working collaboratively with international partners to support registration projects (incl. new registrations, renewals, tenders and deficiencies) in markets throughout the EMEA region.• Assessing impact of product changes (e.g. design, manufacturing & labelling changes) on international registrations.• Maintaining regulatory records in various digital database platforms (incl. SAP, Excel).

Winterthur Und Umgebung, Schweiz

• Development of European Medical Device Regulation (EU MDR) documentation.• Implementiation of MDR-related changes to company-wide procedures.• Co-ordination of inputs from working group delegates throughout the company.

Winterthur Area, Switzerland

• Worked together with RA teams in various countries to support the re-registration of medical devices associated with an international integration project.• Fostered relationships with suppliers to obtain relevant regulatory documents.• Regulatory review of Standard Assessments, Materials Characterisation reports and other technical documentation.• Utilised the Business Model Canvas (BMC) tool to assist in defining and developing the mission of the new Regulatory Affairs Corporate Services EMEA department.

Potsdam Area, Germany

• Interacted within a team of researchers with a diverse range of technical and cultural backgrounds.• Designed and managed 3D-tissue culture experiments to examine the geometrical effects of biomaterial substrates on bone tissue growth.• Balanced simultaneous projects within tight time limitations.• Fabricated biomaterial scaffolds by rapid prototyping.• Analysed data with software including Excel, MATLAB, Photoshop and Image J.• Extensively utilised phase contrast, confocal and fluorescence microscopy techniques.

• Project: ‘Bone Regeneration using sugar Polymers’ - Investigated the effects of the so-called "sugar polymer", Chitosan on the growth of bone cells to evaluate the potential for use in bone healing tissue engineering applications.• Developed skills in laboratory techniques such as Sterile Cell and Tissue Culture, Cell Viability Assays, Immunocytochemistry, RNA Extraction, Polymerase Chain Reaction, Gel Electrophoresis and Rapid Prototyping as well as Good Laboratory Practice and Laboratory Maintenance.

Bachelor Of Engineering (Materials Science & Engineering)/ Master Biomedical Engineering, Biomedical/Medical Engineering, 1St Class Honours

Completed combined double degree Bachelor of Engineering (with 1st class honours) and Master of Biomedical Engineering, including two.

Tissue Engineering

Completed my master's thesis in collaboration with the Max Planck Institute, Department of Biomaterials, as part of a one semester.

Materials Science

One semester exchange program during my Bachelor Degree.