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... action, and oversee completion of complex labeling projects. Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines ...

Company: Regeneron Ireland DAC (2 weeks ago)

... manufacturing environment, and ideally previous supervisory experience. Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation. Proven experience practicing ...

Company: Stryker Ireland (2 weeks ago)

... . Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO , and ANSI/AAMI/ISO requirements. Please contact Alan ...

Company: ACCPRO (2 weeks ago)

... in: Hands on experience of Clinical Chemistry or Immunology Reagent. Quality assurance, GMP / FDA / ISO regulations. Join our winning team today. Together, well accelerate the real ...

Company: Beckman Coulter Instruments (2 weeks ago)

... , and finished products. Ensure compliance with regulatory requirements (e.g., GMP, ISO, FDA, EPA) and company quality standards. Maintain and review laboratory documentation including test ...

Company: Biocomposites (2 weeks ago)

... and organisational skills. Awareness of regulatory frameworks (e.g., GAMP 5, FDA 21 CFR Part 11) is a plus. ? Why Join? Be part ...

Company: IQVIA (2 weeks ago)

... outsourcing strategies. Maintain knowledge of HA regulations (Swiss medic, OECD, FDA) to support GLP toxicology studies. Potentially serve as a part-time PCS ...

Company: Healthcare Businesswomen’s Association (2 weeks ago)

... of Quality Systems and global vigilance compliance requirements (e.g. ICH, FDA, EMA) including regulations and standards affecting pharmaceutical products, biologics and devices Proven ...

Company: AbbVie (2 weeks ago)

... responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance ... cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, ...

Company: Remepy (3 weeks ago)

... assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software ... 14971) and cybersecurity considerations. Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related ... field Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software ...

Company: CoMind (3 weeks ago)

... , and improvement programs. Regulatory & Compliance Ensure compliance with applicable regulations including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and MDSAP ... Support regulatory submissions (e.g., PMA, IDE, technical files) and interactions with FDA and other global health authorities. Serve as a subject matter expert during audits, inspections ...

Company: OrganOx (3 weeks ago)

... ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards. Good experience in the preparation of Technical Documentation. Good ... of supporting documentation for site MRB meetings. A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory). Proven ability of ...

Company: embecta (3 weeks ago)

... objectives. When required, oversee and/or lead interactions with regulatory agencies (FDA, EMA, etc.) to ensure timely development and approvals. Oversee preparation and submission of ... /or CMC. Experience preparing for and conducting Health Authority Meetings with FDA/EMA/MHRA/local authorities. Strong analytical capabilities. Established credibility ...

Company: Immunocore (3 weeks ago)

... , start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. About CAI CAI is ... , validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are you Ready? Our approach is ...

Company: CAI (3 weeks ago)

... for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements at both the Meiragtx UK and Ireland sites. The role involves life cycle ... a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc. • Proficiency in IT ...

Company: MeiraGTx (3 weeks ago)

... of our digital health platform. You’ll play a critical role in supporting our FDA-regulated digital therapeutics by driving secure, scalable DevOps practices across ... , and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance ...

Company: Remepy (3 weeks ago)

... of our digital health platform. You’ll play a critical role in supporting our FDA-regulated digital therapeutics by driving secure, scalable DevOps practices across ... , and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance ...

Company: Remepy (3 weeks ago)

... preparedness, exploring pathways to medical device certification (e.g. MHRA, DTAC, FDA, NICE) Oversee the development of internal research frameworks to evaluate efficacy and drive ... regulatory requirements and risk management in digital health (e.g. SaMD, MHRA, FDA, ISO) Track record of building and leading cross-functional AI or research ...

Company: webAI (3 weeks ago)

... in a technical or building services or engineering role Experience working in a regulated environment (FDA, NRC or similar) with at least two years' experience in a cGMP environment. Experience ...

Company: CBRE Enterprise EMEA Job type: permanent (3 weeks ago)

... including interfacing (preferably POMSnet). * Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating ...

Company: Team Horizon Job type: contract (3 weeks ago)