MedTech Quality & Regulatory Engineer

King's College London; City of Westminster; On-site; GBP 52,000 - 64,000; Full time

Job summary

King's College London is seeking experts in medical device design regulatory processes to join our Quality and Regulatory Team and work with project groups to translate novel technologies to the clinic.

We aim to advance research and collaboration as part of a hospital-enabled environment, with a fixed-term two-year contract and opportunities to extend, focusing on ISO 13485, MDR and regulatory strategy, design controls and risk management.

Qualifications

• Experience applying quality system standards and regulations (ISO 13485, MDR, 21 CFR 820).
• Ability to write SOPs, templates, and test method instructions.
• Experience with medical device design controls and risk management.

Responsibilities

• Support regulatory strategy and planning for medical devices and SaMD.
• Develop and maintain compliant QMS processes and technical documentation.
• Provide guidance to project teams and identify gaps in information and processes.

Skills

Quality system standards knowledge

Regulatory strategy & planning

Design controls

Risk management

Regulatory affairs for MedTech

Project prioritisation & multi-tasking

Excellent communication

Education

Degree in engineering or related subject

Job description

King's College London is seeking experts in medical device design regulatory processes to join our Quality and Regulatory Team and work with project groups to translate novel technologies to the clinic.

We aim to advance research and collaboration as part of a hospital-enabled environment, with a fixed-term two-year contract and opportunities to extend, focusing on ISO 13485, MDR and regulatory strategy, design controls and risk management.