Medical Technology Jobs

• Bristol
• Hybrid · 2 days in office
• £55,000 – £75,000 pa
• Mid-level
• Permanent

Lead regulatory submissions for Software as a Medical Device products, owning documentation, defining UK, EU and US pathways, and coordinating evidence across software, clinical and quality teams. You'll handle FDA 510(k)/De Novo work, manage regulator and Notified Body interactions, and assess product changes for lifecycle compliance in a small, fast-moving medtech business.

FDA · Notified Bodies

• London
• Hybrid
• Mid-level · manages people
• Permanent

Own the regulatory strategy for a venture-backed medical device company preparing its FDA 510(k) submission. Lead the 510(k) through review, act as primary FDA contact, coordinate test evidence across engineering and CROs, and build US post-market processes while shaping UK and EU MDR strategy.

GUDID

• Newcastle-under-Lyme
• £50,000 – £60,000 pa
• Mid-level

Own and continually improve the Quality Management System in line with ISO 9001 and/or ISO 13485, maintaining documentation, procedures and records. Investigate complaints, supplier issues and non-conformances, lead root cause analysis and CAPA, and conduct internal audits supporting external certification. The role also involves hands-on support for purchasing, goods-in, stock control and warehouse operations.

ERP

• Welwyn Garden City
• £377 – £500 ph
• Mid-level
• Contract

Coordinate early-phase clinical trials within a pharmaceutical Clinical Operations team, covering study start-up, feasibility, timelines, recruitment and vendor oversight. Maintain TMF documentation, risk logs and regulatory compliance under ICH-GCP while working with Data Management, Regulatory Affairs and external partners.

Trial Master Files · Microsoft Office

• Houghton le Spring
• On-site
• Temporary

Support quality assurance, product compliance and regulatory activities in a medical device manufacturing environment. Maintain quality control systems, prepare technical documentation, conduct testing and inspections, investigate non-conformances using CAPA, analyse quality data and support internal and external audits, working closely with the QA Manager and production teams.

ISO 13485 · EU MDR

• Oxford
• On-site
• Mid-level
• Permanent

Accountable for end-to-end delivery of strategic New Product Development programmes, leading multidisciplinary teams across R&D, regulatory, quality, operations and commercial functions. Drives integrated programme plans, stage-gate governance, risk management, resource planning and budget forecasting for complex medical device development in a regulated environment, supporting the metra® organ perfusion platform.

FDA Quality System · Design History Files

• Houghton le Spring
• On-site
• Mid-level
• Temporary

Support the design, manufacture, testing and regulatory compliance of medical devices, maintaining quality control systems, production protocols and documentation. Investigate non-conformances and complaints, run CAPA, testing and validation, and assist with EU MDR, ISO 13485 and audit readiness, including clean room operations.

• Cambridge
• Senior
• Permanent

Lead medical device development projects while working hands-on as a senior mechanical engineer, collaborating with multidisciplinary experts in mechanical, electronics and biomedical fields. Requires several years of mechanical design experience in medical devices, with any 3D CAD tool acceptable and SolidWorks advantageous.

SolidWorks

• United Kingdom, YY9 9YY
• Remote
• Mid-level

Provides day-to-day medical oversight for one or more clinical trials, ensuring patient safety, data integrity and protocol compliance. Reviews and assesses AEs and SAEs, supports safety signal detection with Pharmacovigilance, and advises investigators on eligibility and dosing. Works cross-functionally with Clinical Operations, Data Management, Biostatistics and Regulatory Affairs, and contributes to CSRs and regulatory submissions.

Data Safety Monitoring Boards

• Oxford
• On-site
• Mid-level
• Permanent

Assures software quality across the full lifecycle for medical devices up to IEC 62304 safety class C, covering design controls, requirements, verification and validation, and release management. A central duty is software risk management, developing and maintaining SFMEAs, hazard analyses and cybersecurity risk assessments aligned with ISO 14971. Works with R&D, Engineering, Post-Market Operations, Regulatory Affairs and Cybersecurity to support EU MDR and FDA compliance.

IEC 62304 · ISO 14971 · ISO 13485 +5

• Hamburg, Germany
• €93,500 – €149,845 pa
• Mid-level

Field-based medical affairs role supporting Shockwave Medical's cardiovascular portfolio across Europe. Builds relationships with key opinion leaders, oversees investigator-initiated studies, reviews promotional materials, and provides scientific and HEOR support to cross-functional teams. Requires frequent conference attendance and up to 50% travel.

Microsoft Office · Word · Excel +3

• Wokingham
• €93,500 – €149,845 pa
• Mid-level

Field-based Medical Affairs role supporting Shockwave Medical's cardiovascular portfolio across Europe. Builds relationships with key opinion leaders, supports investigator-initiated studies, reviews promotional materials, and provides scientific and HEOR support to cross-functional teams. Requires frequent conference attendance and up to 50% travel.

Microsoft Office · Microsoft Word · Microsoft Excel +3

• Cambridge
• Mid-level

Provide regulatory support across a Cambridge product development business, guiding multidisciplinary engineering and science teams on compliance with ISO 9001, ISO 13485 and FDA 21 CFR 820. Monitor international regulatory changes, support external audits and contribute to quality management system improvements across medical and non-medical projects.

• Henley-on-Thames
• £32,000 – £38,000 pa
• Mid-level
• Permanent

Support regulatory affairs and compliance across healthcare, digital health and medical-device activity. Maintain the Quality Management System, medical-device technical documentation, risk registers and audit actions, while coordinating evidence for tenders, CQC inspections and information governance. Acts as a link between clinical, technical and commercial teams.

ISO 13485 · ISO 14971 · IEC 62304 +7