BioTalent

About the Company

We are BioTalent, the life sciences recruitment specialists with the means to nurture change-makers.

Our expert consultants focus on Medical Communications, Healthcare Advertising and public Relations, Market Access, Research and development, Data Science & AI, Clinical, Regulatory, Engineering & CQV, Manufacturing & Operation, Quality, Medical and Drug Safety, and Commercial.

We have a global reach, with offices in the UK (London), Switzerland (Zug), and the USA (New York, San Diego, Miami and Boston).

We are part of The IN Group a collection of specialist talent brands – Investigo, InX, Definia, Caraffi, Sigma Labs and BioTalent – who partner with our clients to solve their talent challenges, across the UK, Europe and North America.

Are you ready to find your calling in the life sciences? Reach out to us directly to find your next opportunity, or visit https://www.biotalent.com/ to find out more.

Listed Jobs

Company Name

BioTalent

Job Title

Quality Assurance Consultant

Job Description

Job Title: Quality Assurance Consultant Role Summary: Junior‑mid level QA professional responsible for implementing and maintaining ISO 13485‑compliant quality systems in a diagnostics startup, collaborating with laboratory teams to validate processes, manage data, and ensure regulatory readiness during scale‑up. Expectations: - Execute QA duties in a fast‑paced, evolving environment. - Actively contribute to process creation and improvement rather than only review. - Maintain detailed, audit‑ready documentation and timely issue escalation. Key Responsibilities: - Implement ISO 13485 processes and verify compliance with regulatory standards. - Partner with lab teams to validate inventory management tools and document procedures. - Create and maintain data logs for media labs; confirm reagents, products, and consumables meet quality standards. - Support inventory management, equipment scheduling, preventive maintenance, and calibration tracking. - Detect, document, and promptly report issues; ensure documentation is accurate and audit‑ready. - Develop and execute new QA processes as the company scales, accommodating facility moves or system expansions. Required Skills: - 1–4 years of Quality Assurance experience in life sciences, medtech, diagnostics, or IVD. - Familiarity with ISO 13485 and related quality system requirements. - Strong scientific background (Engineering, Biology, Life Sciences, or related field). - Detail‑oriented, organized, and adept at building processes from scratch. - Hands‑on contributor with a proactive, execution‑focused mindset. Required Education & Certifications: - Bachelor’s degree in Engineering, Biology, Life Sciences, or a related scientific discipline. - ISO 13485 audit or QA certification preferred (e.g., ISO/IEC 17025, ISO 9001).

San diego, United states

Hybrid

Fresher

12-09-2025

Company Name

BioTalent

Job Title

Quality System Specialist

Job Description

San francisco bay, United states

Hybrid

Mid level

12-09-2025

Company Name

BioTalent

Job Title

Quality Engineer

Job Description

**Job Title** Quality Engineer **Role Summary** Provide design control and risk management for medical device and combination product development, ensuring regulatory compliance, supporting submissions, audits, and cross‑functional collaboration. **Expectations** - Self‑motivated, detail‑oriented, and able to manage multiple priorities. - Strong communicator with cross‑functional teams. - Proactive problem‑solver who drives quality improvements. **Key Responsibilities** - Lead design control and risk management activities across development, clinical, and commercial programmes. - Ensure compliance with ISO 13485, ISO 14971, 21 CFR 820/4, and EU MDR. - Collaborate with external design and manufacturing partners on risk management and design verification. - Contribute to human factors engineering and usability assessments. - Support regulatory submissions, audits, and investigations related to device design and manufacturing. **Required Skills** - In‑depth knowledge of ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR, EN 62366, EN 60601, EN 62304. - Experience in medical device or combination product development. - Proficient in design control, risk management, and human factors practices. - Strong analytical, documentation, and problem‑solving capabilities. - Effective written and verbal communication; ability to collaborate with cross‑functional teams. **Required Education & Certifications** - Bachelor’s, Master’s, or Ph.D. in Science or Engineering discipline. - ISO 13485 Lead Auditor, ISO 14971 Risk Management, or equivalent certification preferred.

Cambridge, United kingdom

Hybrid

04-11-2025

Company Name

BioTalent

Job Title

Senior Full Stack Engineer

Job Description

Job title: Senior Full Stack Engineer Role Summary: Lead the design, development, and scaling of AI‑powered full‑stack systems for real‑time voice‑based healthcare workflows. Collaborate with product, engineering, and clinical stakeholders to deliver secure, high‑performance, production‑grade solutions. Expectations: • 3–6 years of full‑stack experience in TypeScript, Node.js, React, and PostgreSQL. • Proven track record of building scalable, production‑grade systems in fast‑paced or startup environments. • Strong architectural judgment and the ability to work autonomously across the stack. • Proactive, adaptable, and comfortable navigating ambiguity. Key Responsibilities: • Design, build, and scale end‑to‑end systems that integrate generative AI agents into clinical operations. • Deploy and optimise real‑time, voice‑based AI models, ensuring low latency and high reliability. • Define and enforce scalable architecture, data security, and compliance standards. • Identify and implement high‑impact improvements that enhance efficiency, reliability, and user experience. Required Skills: • Deep expertise in TypeScript, Node.js, React, and PostgreSQL. • Experience architecting and operating large‑scale, production‑grade web applications. • Knowledge of AI/ML, generative models, or conversational technologies (desired). • Familiarity with LLM integration, voice infrastructure, or healthcare interoperability (desired). Required Education & Certifications: • Bachelor’s degree in Computer Science, Software Engineering, or related field (preferred). • Relevant industry certifications (e.g., AWS Certified Developer, Google Cloud Professional Data Engineer) are a plus.

New york city, United states

On site

Senior

05-11-2025