Carreiras

Roles and Responsibilities:

• Organise and chair Risk Meetings, including updating risk documents, taking minutes, distributing minutes and following up on any actions.
• Technical file maintenance including creating templates and documentation.
• Support the QA & RA Assistant with the Change Note Process and any additional tasks. 
• Supporting the QA Officer with the Post Market Surveillance process, including data gathering, report updating and liaising with department managers internally.
• Updating KPI reports for the QA & RA Department.
• Assisting in dealing with quality non-conformances raised internally.
• Support with registrations where necessary for the RA Team
• Liaising with Distributors and Suppliers
• Submitting confidential documents to Suppliers
• Spreadsheet and Monday board maintenance including the Planning Workbook
• General office administration

Como Associado de Assuntos Clínicos, você coordenará as principais atividades clínicas e regulatórias, incluindo avaliação clínica, Vigilância Pós-Mercado (PMS), Acompanhamento Clínico Pós-Mercado (PMCF) e gerenciamento de risco para dispositivos médicos. Você trabalhará em estreita colaboração com a pequena equipe de Assuntos Clínicos e Médicos, contribuindo para o desenvolvimento bem-sucedido, introdução no mercado e manutenção de dispositivos médicos seguros e eficazes. Você também auxiliará com solicitações de subsídios para garantir financiamento para pesquisa e desenvolvimento clínicos.

Avaliação clínica:

• Ajude a coordenar e manter planos e relatórios de avaliação clínica com a consultoria designada, garantindo a conformidade com os procedimentos da empresa e os padrões regulatórios.

Vigilância Pós-Comercialização (PMS):

• Auxiliar na coleta e análise de dados clínicos para dar suporte à segurança do dispositivo, atualizar arquivos de gerenciamento de risco e identificar possíveis melhorias.

Acompanhamento clínico pós-comercialização (PMCF):

• Contribuir para estudos do PMCF, incluindo a preparação de planos, o gerenciamento da coleta de dados e a criação de relatórios para garantir a conformidade com os regulamentos.

Gestão de Riscos:

• Colaborar com a equipe de gerenciamento de risco, incluindo revisões periódicas de risco para integrar dados clínicos no arquivo de gerenciamento de risco (RMF).
• Auxiliar na avaliação de riscos associados a estudos clínicos e dados pós-comercialização para dar suporte à segurança do dispositivo.

Biocompatibilidade:

• Auxiliar na coordenação de testes e avaliações de biocompatibilidade com a consultoria designada para garantir que os materiais do dispositivo sejam seguros para uso humano.
• Apoiar o desenvolvimento de documentação de biocompatibilidade, incluindo planos de teste, relatórios e submissões regulatórias, garantindo a conformidade com a ISO 10993 e padrões relacionados.

Desenvolvimento e atualizações de SOP

• Ajude a atualizar e manter os Procedimentos Operacionais Padrão (POPs) para atividades clínicas, garantindo que estejam alinhados com os regulamentos atuais e as melhores práticas.

Suporte para solicitação de subsídios

• Auxiliar na identificação de oportunidades de financiamento e na preparação de solicitações de subsídios para pesquisa e desenvolvimento clínico.

As a Medical Writer will be part of the growing Clinical department at Bedfont. The Medical Writer specialises in medical devices and plays a crucial role in creating compelling and accurate content to support development, regulatory approval, and marketing.

Working closely with cross-functional teams, including Research & Development, Quality Assurance & Regulatory Affairs, and Marketing, the Medical Writer translates complex scientific and technical information into clear and engaging content tailored to various audiences, including healthcare professionals, regulatory agencies, and consumers.

• Collaborate with cross-functional teams to understand product specifications, clinical data, and regulatory requirements for medical devices
• Write and edit a variety of scientific and technical documents, including clinical study reports, regulatory submissions, product manuals, and marketing materials.
• Prepare clear, concise, and scientifically sound clinical documentation, including, but not limited to, Clinical Evaluation Plans (CEPs) and reports and Post Market Clinical Follow-Up (PMCF) plans and reports in accordance with medical device regulatory requirements and industry best practices.
• Perform regular quality control testing of test equipment and organise test data for analysis
• Help manage clinical evaluation processes to include developing detailed plans for conducting clinical evaluations, outlining objectives, methodologies, data sources and timelines.
• Conduct comprehensive Systematic Literature Reviews (SLRs) to gather relevant clinical data on similar medical devices, treatments, or technologies, and identify and review clinical studies, trials, and reports related to the medical device under evaluation.
• Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., MEDDEV 2.7/1, MDR, FDA guidance).

As a Warehouse Operator you will be responsible for assisting with the daily warehouse and global despatch activities in a busy and hands on Operations Department. You will be working in a small team and helping to complete monthly stock counts and annual stock takes.

• Processing, picking, packing, final invoicing and arranging delivery of customer orders
• Liaising with sales/production/couriers to troubleshoot and resolve issues ensuring cost and delivery efficiency
• Liaising with sales/production/Senior Stock Controller to ensure orders are dispatched on time
• Maintaining concise warehouse and despatch records
• Completing quality checks on incoming goods and ensuring correct storage conditions are met
• Ensuring accurate stock management through LV software
• Assisting with annual full stock takes
• Assisting with monthly stock counts
• Helping with the delivery and collection of exhibition equipment and goods
• Taking part in Health & Safety tasks in the warehouse and dispatch environments

As the subject expert and sole Software Developer at Bedfont Scientific Ltd you will create innovative software solutions. You will predominantly be creating desktop applications to interface with Bedfont’s medical devices using USB and Bluetooth protocols. You will design intuitive and user-friendly graphical user interfaces (GUIs), enabling storage of patient results and communicating with hospital systems.

• Design and develop new desktop software applications specifically tailored to interface with Bedfont’s new and existing medical devices.
• Maintain existing desktop software applications.
• Collaborate with small cross-functional teams, including R&D, Regulatory Affairs and Marketing to define system requirements.
• Develop user-friendly interfaces for both patients and healthcare providers, enhancing accessibility and usability.
• Implement robust security measures to protect sensitive patient data in compliance with HIPAA, GDPR, Cybersecurity and other regulatory standards.
• Conduct testing and debugging of applications to ensure reliability and functionality across multiple platforms and devices prior to prerelease testing.
• Create and maintain documentation throughout the software development process to ensure adherence to industry and medical device standards (such as IEC 62304).
• Responsible for reporting the latest advancements in software languages, development tools and vulnerabilities.
• Participate in Technical Team Innovation Days specifically focused on developing cutting-edge technology.