6 of 6 Remote Permanent 21 CFR Part 11 Jobs

experience in cleaning, process equipements. You have at least 5 years of experience in a pharmaceutical with a focus on delivering solution. You have excellent understanding of GxP regulations, 21 CFR Part 11, Eudralex Annex 11 or other international requirements. You are proficiency in French and English, both written and spoken. You have proven experience More ❯

consistency across regulatory processes. 10+ years of experience in software lifecycle management and validation, with emphasis on pharma or biotech compliance. Solid knowledge of EU regulatory frameworks (e.g., GxP, 21 CFR Part 11, Annex 11). Experience preparing for and navigating ISO, SOC, and other third-party compliance audits. Strong documentation, project management, and cross More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We More ❯

feedback. Emit structured telemetry events to data pipelines for model retraining. Ensure WCAG 2.2 AA compliance, semantic HTML, keyboard navigation, and screen-reader support. Adhere to internal branding and 21 CFR Part 11 considerations in regulated contexts. Own GitHub workflows: branching strategy, GitHub Actions pipelines, automated testing, and artifact deployment. Containerize and deploy the SPA via More ❯

About the Role We're hiring a Pre-Sales Technical Consultantto join a dynamic, mission-driven team transforming the way clinical trials are run. As part of a fast-growing healthtech startup, you'll play a key role in supporting commercial growth by bridging the gap between client needs and product capability. You'll work closely with both the … SaaS, cloud, or digital health. Strong understanding of enterprise sales cycles and client engagement across regulated industries. Clinical trial tech knowledge and familiarity with sector-specific standards (e.g. GCP, 21 CFR Part 11, GDPR) is a major plus. Excellent communication skills with the ability to present technical topics to both technical and non-technical audiences. Comfortable More ❯

and standards for all applicable markets, including but not limited to: Hazardous Chemicals: UK & EU REACH, RoHS, California Proposition 65, AB1200 Food Contact Materials: EU 10/2011, FDA 21 CFR 175-178 Electrical & Electronic Products: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Battery Directive (2006/66/EC More ❯