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... relevant scientific and/or medical knowledge and expertise. - Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. - Demonstrated ... Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across ...

Company: Syneos Health Careers (2 days ago)

... technologies. This is a high-impact, hands-on leadership role supporting both FDA and IVDR pathways, ideal for someone who thrives in a collaborative, cross-functional ... experience in regulatory affairs within the IVD, diagnostics, or medical device sectors Demonstrated success with FDA submissions (e.g., 510(k), Pre-Subs) Strong working knowledge ...

Company: Hartmann Young (2 days ago)

... Persistence is preparing to launch two new Foundation Degrees in the following areas: - FdA Business and Innovation The programme features modules on: Skills for Study and Work, Principles of ... Southall, England, United Kingdom 1 week ago Lecturer in Business and Hospitality (FdA Programme) London, England, United Kingdom 1 month ago London, England ...

Company: Arden University (2 days ago)

... a portfolio already containing client names such as DHL, Johnson & Johnson, FDA, DMV, PwC, KeyBank, Spotify, and H&R BLOCK. ABBYY is expanding ... , including many Fortune 500 ones, with names such as DHL, Johnson & Johnson, FDA, DMV, PwC, KeyBank, Spotify, and H&R BLOCK; We have modernized the capture ...

Company: ABBYY (1 day ago)

... the broader life sciences/healthcare/med tech ecosystem, including ISO 14971, FDA, MDCG, IMDRF, and ICH guidelines for classifying and reporting medical device and drug adverse ... management, compliance or post market safety. Fluent in Medical Device regulations- EUMDR, FDA, ISO13485 Competent in Microsoft Office programs (e.g., Word, Excel, and ...

Company: Insulet Corporation (1 day ago)

... Synergy Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage ... physicians treat even the most complex cases. We’re proud to offer: The first and only FDA-approved device for long-standing persistent Afib (Isolator Synergy System) The world ...

Company: AtriCure, (1 day ago)

... solutions. Stay ahead of evolving regulatory landscapes (UK, EU, FDA) and effectively communicate their impact to stakeholders. Oversee the planning, coordination, and ... and developing regulatory teams. Deep and current knowledge of UK, EU, and FDA regulatory requirements and guidelines. Exceptional strategic thinking, leadership, and communication ...

Company: Genomics (1 day ago)

... responsible for making sure the business meets or exceeds quality standards including FDA and ISO compliance. Additionally, you will champion and drive forward the ... . Approve company operational procedures, policies, and standards and assure compliance with FDA, GMP and ISO quality standards. Review activity reports and financial statements to ...

Company: Guided Solutions (10 hours ago)

... clear direction, support and development. Oversee the QMS and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and EN 62304. Govern quality ... in the Medical Device industry. Strong knowledge of ISO 13485, EU MDR, FDA QSR and EN 62304. Background in Software as a Medical Device (SaMD) is ...

Company: Cure Talent (10 hours ago)

... through commercialization. Establish and maintain robust interfaces with regulatory agencies (e.g., FDA, EMA) and notified bodies, assuming accountability for CMC sections of regulatory ... , MAAs). Strong experience working with global regulatory agencies (e.g., FDA, EMA) and managing international supply chains. Proven experience working in small or ...

(2 hours ago)

... design principles across all touchpoints. Navigating healthcare regulations (e.g., ABPI, FDA, EMA) while maintaining creative excellence. Driving operational excellence by managing ...

Company: Havas Job type: permanent (1 day ago)

... and construction is essential. Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines Find out more about PM Group and our projects. Why PM ...

Company: PM Group Job type: permanent (10 hours ago)

... and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO ...

Company: Mech Tech Professionals Job type: permanent (4 days ago)

... degree or equivalent technical experience. Strong knowledge of analytical methods, ISO/FDA standards, and equipment. Experience managing third party accreditations. Comfortable managing performance ...

Company: Zest Job type: permanent (3 days ago)

... devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance Experience in writing formative andsummative usability test protocols ...

Company: Real Job type: contract (3 days ago)

... efficiency and high service standards Ensure full adherence to shipping regulations, including FDA requirements for applicable shipments Prepare and maintain accurate documentation and shipping records Partner ...

Company: KPI Recruiting (1 day ago)

... : QA, quality assurance, compliance, documentation control, document, SOP, GMP, MHRA, FDA, ISO, UKAS, manufacturing, production, healthcare, medical, pharmaceutical, biopharmaceutical, biotechnology, nutraceutical ...

Company: RBW Consulting Job type: permanent (1 day ago)

... documentation Ensure all projects adhere to local and international regulatory standards (e.g., FDA, EMA, OSHA) Promote and maintain a strong safety culture throughout all project ...

Company: PM Group (2 days ago)

... Data-driven problem solver with rapid troubleshooting abilities Familiarity with ISO 13485 and FDA standards Preferred Qualifications Degree in Engineering, Operations, Manufacturing, or related field Lean ...

Company: Sterling Engineering (2 days ago)

... knowledge of ISO 13485, ISO 14971, EU MDR 2017/745, and FDA QSRs is preferred. Strong communication and organizational skills, with attention to detail in documentation ...

Company: Gi Group (2 days ago)