Senior Regulatory & Quality Lead, MedTech & SaMD

King's College London; Greater London; On-site; GBP 55,000 - 90,000; Full time

Job summary

King's College London is seeking experts in medical device design regulatory processes to translate novel technologies to the clinic. The role supports MedTech Venture Builder and Accelerator programs, developing class I to III devices and ensuring ISO 13485 QMS compliance.

Based in LIHE, School of Biomedical Engineering and Imaging Sciences, you will guide project teams on regulatory strategy, quality systems, and documentation, while coordinating with start-ups and external stakeholders.

Qualifications

• Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
• Knowledge of applying quality system standards and regulation (ISO 13485, 21 CFR 820, AIMD, MDD/MDR).
• Experience applying design controls and risk management to medical devices or SaMD.
• Ability to understand regulatory needs and provide strategic advice for multiple medical device types.
• Experience applying quality system procedures; experience preparing SOPs, templates, test methods.

Responsibilities

• Provide guidance on regulatory strategy and planning for medical devices and SaMD.
• Develop and maintain compliant processes and technical documentation per stakeholders.
• Operate within QMS meeting ISO 13485 and relevant standards.
• Support regulatory submissions and quality system procedures; identify gaps and propose solutions.
• Collaborate with project teams and start-ups in MedTech Venture Builder and Accelerator.

Skills

Quality management

Regulatory strategy

Design controls

ISO 13485

MDR/MDD

Regulatory submissions

Auditing

SaMD development

Regulatory affairs for MedTech

Documentation

Project prioritisation

Team collaboration

ISO 62366-1

IEC 62304

IEC 60601 series

ISO 10993

Education

Degree or equivalent in engineering or related quality/regulatory field

Job description

King's College London is seeking experts in medical device design regulatory processes to translate novel technologies to the clinic. The role supports MedTech Venture Builder and Accelerator programs, developing class I to III devices and ensuring ISO 13485 QMS compliance.

Based in LIHE, School of Biomedical Engineering and Imaging Sciences, you will guide project teams on regulatory strategy, quality systems, and documentation, while coordinating with start-ups and external stakeholders.