RA/QA Manager

Signatur Biosciences Ltd; Greater London; Hybrid; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Equity

3 weeks PTO

Private medical insurance

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Prioritization

Interdisciplinary collaboration

Note-taking

Education

Bachelor of Science in biology-related field

Tools

QMS

Job description

Signatur Biosciences was established with the mission of making cutting-edge diagnostic tools accessible to more patients around the world. The development of precision diagnostics has increasingly driven advances in life-saving personalized medicine, yet those innovations come with an ever-increasing price tag. Major players in molecular diagnostics have prioritized more and more complex and expensive equipment, rendering these advances inaccessible to many unless we do something about it.

Leveraging groundbreaking innovations in molecular design, we develop high-performance diagnostic tests that are specifically designed to run on equipment already found in biomedical labs around the world. We\'re worried about accessibility in precision diagnostics and are building a team of individuals who share our passion for solving this problem through close collaboration and a sense of urgency. We\'re building a different kind of company, where employees think like owners, act with authority, and collaborate closely with one another.

Signatur Biosciences is a spinout of Imperial College London, backed by YCombinator and based in New Heaven, Connecticut, and London, UK. We seek a highly motivated and driven RA/QA Engineer to join our London team (remote work could be available). In this role, you’ll work closely with the CEO and CSO. You will be responsible for Regulatory Affairs and Quality Assurance activities. You will also be exposed to Clinical activities, and you will work closely with a team of interdisciplinary scientists to develop, validate, and commercialize our diagnostics assays. If you are a self-starter with a passion for novel diagnostics development, we\'d love to speak with you!

Responsibilities:

• Define and implement a Regulatory Strategy embedded within our Product Development Plan.
• Interaction with Regulatory Bodies. Lead FDA/EU pre-submissions and submissions.
• QMS implementation and orchestration. Collaborate with and support the CSO and scientists.
• Support Clinical activities, including the design and implementation of our clinical studies.

Nice-to-haves (but not required):

• Speak more than one language.

Qualifications:

• Over 3 years of relevant industry experience, preferably within IVD/molecular diagnostics.
• Led and navigated at least one IVD regulatory submission, demonstrating leadership and broad exposure. Hands-on experience with FDA/MDR submissions, including preparing documentation and liaising with FDA and notified bodies/regulatory authorities.
• Experience with QMS development and implementation activities followed by certification/ orchestrating the internal and external audit — owning the QMS.
• Bachelor of Science degree in biology, molecular biology, synthetic biology, bioengineering, or similar.
• Excellent attention to detail, backed by exceptional note-taking and record-keeping skills.
• Ability to effectively prioritize tasks in a dynamic and fast-paced environment
• Excellent communication skills. Strong interest in interdisciplinary work, willingness to dive into new topics, and understanding medical requirements.

Compensation and benefits at Signatur Biosciences include:

• Base Salary + Equity (compensation will be based on experience level with requested qualifications).
• Generous paid time off policy that includes: 3 weeks, approximately 1 additional week during year-end holidays.
• Private medical insurance could be offered.
• As we continue to grow, our benefits package will evolve. Benefits outlined above are accurate as of the job posting date, but may differ at time of hire.

Further information

Signatur Biosciences is an equal-opportunity employer promoting diversity and inclusion in the workspace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

Legal authorization to work in the UK is required. In compliance with UK law, all persons hired will be required to verify identity and eligibility to work in the UK and to complete the required employment eligibility verification form upon hire.