Senior RA/QA Lead, IVD Diagnostics & Compliance

Signatur Biosciences; Greater London; Hybrid; GBP 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Equity

3 weeks PTO

Private medical insurance

Zusammenfassung

Signatur Biosciences is seeking a motivated RA/QA Engineer to join our London team, with potential remote work. You will define regulatory strategy and lead regulatory submissions, while implementing a robust QMS and supporting clinical activities in collaboration with the CSO and other scientists.

The ideal candidate brings 3+ years in IVD/molecular diagnostics, hands-on FDA/MDR submission experience, and a biology-based degree, with a readiness to grow in a fast-paced mission-driven company.

Qualifikationen

• 3+ years of relevant industry experience in IVD/molecular diagnostics.
• Led at least one IVD regulatory submission, including FDA/MDR submissions.
• Experience with QMS development and audit orchestration.
• BS degree in biology, molecular biology, synthetic biology, bioengineering, or related field.
• Excellent attention to detail and meticulous record-keeping.
• Strong prioritization and communication in a fast-paced, interdisciplinary setting.

Aufgaben

• Define and implement regulatory strategy within the Product Development Plan.
• Interact with regulatory bodies; lead FDA/EU pre-submissions and submissions.
• Develop and orchestrate QMS; support CSO and scientists.
• Support clinical activities, including design and execution of clinical studies.

Kenntnisse

Attention to detail

Communication skills

Prioritization

Interdisciplinary collaboration

Note-taking

Ausbildung

Bachelor of Science in biology-related field

Tools

QMS

Jobbeschreibung

Signatur Biosciences is seeking a motivated RA/QA Engineer to join our London team, with potential remote work. You will define regulatory strategy and lead regulatory submissions, while implementing a robust QMS and supporting clinical activities in collaboration with the CSO and other scientists.

The ideal candidate brings 3+ years in IVD/molecular diagnostics, hands-on FDA/MDR submission experience, and a biology-based degree, with a readiness to grow in a fast-paced mission-driven company.