... balancing electrical, mechanical, and biocompatibility requirements while ensuring designs meet stringent safety and regulatory standards (IEC 60601, ISO 13485, FDA 510(k)/PMA pathways). Lead System Design & Engineering Lead the end-to-end design of external defibrillator electrode/lead systems, including pad electrodes, ...
India, Bengaluru
View vacancy... able to envisage new and better ways of doing things. - Excellent analytical skills, ability to plan, organise and implement concurrent tasks. - Experience in an FDA regulated or regulated industry beneficial. - High level of PC Skills required. - Fundamental knowledge and understanding of mechanical engineering practices ...
22137 - 50k
... custom formulations. - A 50,000 sq ft fully automated plant in Jaipur, scaled from a 5,000 sq ft manual operation in five years. - BRCGS Grade A, FSSC 22000, US FDA, EU Organic, USDA Organic/NOP, NPOP, Kosher, GMP, Halal and SEDEX/SMETA — more than ten active certifications. - A farmer network of 500+ certified farmers and ...
India, Jaipur
View vacancy... You'll define and advance quality and compliance strategies for SAP products and cloud services, ensuring alignment with global regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5. Your expertise will help SAP and its customers confidently adopt innovative technologies while maintaining ...
India, Bengaluru
View vacancy... requirements are incorporated into product design, development, verification, validation, and post-market activities. Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks. Author and maintain regulatory documentation including technical ...
India, Bengaluru
View vacancy... subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired - FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desired - Statistics knowledge ...
India, Bengaluru
View vacancy... requirements are incorporated into product design, development, verification, validation, and post-market activities. - Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks. - Author and maintain regulatory documentation including ...
India, Bengaluru
View vacancy... subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desired Statistics knowledge ...
India, Bengaluru
View vacancyJob Title: Regulatory & Technical Writer Experience 1–2 years (hands-on ownership in Regulatory [CDSCO, ISO, FDA] documentation) About the Role We are seeking an experienced Technical Writer to support our AI team with regulatory and compliance documentation for AI-enabled medical devices and software (SaMD). This role ...
25k
... treatment of AVN, chronic back, neck, and knee pain, the center has successfully helped over 25,000 patients avoid surgery with a 90% success rate. Using advanced FDA-approved technologies, such as high-power lasers, targeted robotics spinal disc decompression, and regenerative medicine, the center focuses on repairing and ...
... simulation tools such as PSpice. - Experience in wireless technologies such as BLE, Wi-Fi, Zigbee, etc. Desirable Skills: - Experience in a regulated industry (FDA strongly preferred). - Six Sigma Black Belt certification. - Experience with Altium and Mentor Graphics tools for PCBA design. - Experience in defining, designing, ...
India, Coimbatore
View vacancy... spirit needed to thrive in our organization. About the Role Azurity is seeking a Manager to execute QA Operations internationally to ensure full compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP regulations and guidelines. As part of these core responsibilities, this role will support Global Quality Operations including ...
... systems (e.g., LIMS, ERP, eQMS, cloud platforms, SaaS) - Strong technical writing skills and attention to detail for documentation - Experience supporting audits by FDA, EMA, or other regulatory bodies - Ability to lead validation projects independently from planning through execution and closure - Familiarity with change control, ...
... • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution ...
... work-related duties as assigned. - Minimal travel may be required (less than 25%). Get to know Syneos 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 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
... work-related duties as assigned. - Minimal travel may be required (less than 25%). Get to know Syneos 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 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India, Bhavnagar
View vacancy... Health or client related) and completion of all designated required training. Get to know Syneos 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 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
... evidence generation processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with regulatory guidelines (FDA and EMA) and COA contributions as appropriate to other submissions in collaboration with the senior team members - (2) Maintain adherence to the evidence generation ...