SaMD Regulatory Lead — Hybrid & 10% Bonus

Sustainable Infrastructure; West of England; Hybrid; GBP 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Hybrid working

Two fixed office days per week (Wed &

Two fixed office days per week (Wed &

Zusammenfassung

Sustainable Infrastructure is seeking a hands-on Regulatory Affairs Manager in Bristol to lead regulatory submissions for software-based medical devices (SaMD). You will define pathways, coordinate evidence, and ensure lifecycle compliance across UK, EU and US markets.

Collaborate with software, clinical, product and quality teams to deliver robust submissions, manage regulator interactions, and guide regulatory strategy in a growing tech-enabled medical device company.

Qualifikationen

• Hands-on regulatory affairs for Software as a Medical Device (SaMD) or software-driven medical devices.
• Experience writing and preparing regulatory submission documentation.
• Knowledge of UK/EU medical device frameworks and US FDA requirements.

Aufgaben

• Lead the preparation, writing and coordination of regulatory submissions for SaMD products.
• Develop regulatory strategies and device classifications for UK, EU and US markets.
• Prepare regulatory documentation and respond to regulator questions.

Kenntnisse

SaMD experience

Regulatory submissions

UK/EU/US regulatory

Jobbeschreibung

Sustainable Infrastructure is seeking a hands-on Regulatory Affairs Manager in Bristol to lead regulatory submissions for software-based medical devices (SaMD). You will define pathways, coordinate evidence, and ensure lifecycle compliance across UK, EU and US markets.

Collaborate with software, clinical, product and quality teams to deliver robust submissions, manage regulator interactions, and guide regulatory strategy in a growing tech-enabled medical device company.