669 Fda Jobs

Key Responsibilities: 1. Product Registration & Approvals: Independently manage the full lifecycle of product dossiers and lead registration, renewals, and post-approval updates. Identify, analyse, and communicate relevant domestic and international regulations impacting product registration for all assigned markets, ensuring the team is informed of regulatory changes affecting submission strategies. Lead the preparation and coordination of regulatory submissions for each product launch, ensuring all requirements and deadlines are met for timely approvals. Oversee approval timelines, identify possible delays, and implement corrective actions to meet deadlines. 2. Team Leadership & Cross-Func...

shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Label artwork review and management Required Candidate profile Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

JD # 1 - ALTERYX ARCHITECT Experience: 10+ years (including 45 years on Alteryx platform) Employment Type: Full-time Role Overview We are looking for an experienced Alteryx Architect to lead the design and delivery of enterprise-grade analytics and automation workflows within the Healthcare & Life Sciences (HLS) domain . This role involves building scalable solutions that integrate data from clinical, operational, and regulatory sources, ensuring compliance with healthcare data standards. Key Responsibilities Design end-to-end data workflow architecture using Alteryx Designer, Server, and Connect. Translate HLS use cases into technical workflows, including patient journey analytics, claims a...

We are looking for a compliance engineer/component engineer who is trying to further his career to presales and customer management roles. Responsible for identifying markets and developing solutions. Responsible for supporting sales/inside sales team on convincing customers with documents, samples and discussions Well versed with compliance regulations like RoHS, REACH, PFAS, Conflict minerals etc Well versed with component engineering activities like part selection, alternate development etc Identifying target companies to work with sales for pitching our services Knowledge in Electronic Components / Cost Analysis/ Electronic Component Datasheet study for Form Fit Function comparison. Appl...

Responsibilities: Experience interacting with global regulatory agencies FDA., Knowledge of QMS Prepare and submit regulatory documentation to authorities across global markets Promotional approval for medical devices and pharmaceutical products

As a Sales Manager in Healthcare & Life Sciences at Yethi, you will play a crucial role in developing and executing sales strategies targeting healthcare providers and life sciences organizations. Your responsibilities will include identifying and engaging potential clients, building strong relationships with key stakeholders such as CTOs, CIOs, Compliance Heads, and Quality Assurance leaders. You will be promoting test automation solutions for HL7 & ICD upgradation, risk-based testing using FMECA, and TCoEs for functional & non-functional testing. Additionally, you will drive new business development through outreach, networking, and participation in industry events. Collaboration with pre-...

Ways of working : Mandate 3 Employees will come to the office everyday at their base location. About Swiggy Instamart Swiggy Instamart, is building the convenience grocery segment in India. We offer more than 30000 + assortments / products to our customers within 10-15 mins. We are striving to augment our consumer promise of enabling unparalleled convenience by making grocery delivery instant and delightful. Instamart has been operating in 90+ cities across India and plan to expand to a few more soon. We have seen immense love from the customers till now and are excited to redefine how India shops. Position: Assistant Manager Regulatory (Private Label Business) Function: Regulatory & Complia...

Job Summary: We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access and product lifecycle management. The ideal candidate will have strong knowledge of regulatory guidelines, documentation practices, and submission processes applicable to [pharma / medical device / FMCG] industries. Key Responsibilities: Prepare, compile, and review regulatory documents and dossiers for submission to national and intern...

Urgently Required CSV Trainer For Part Time Basis and Online Training Sessions. Should have Experience in Computer system validation and LIMS Functional Specifications (FS)Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) (FDA, EMA, GAMP 5 Required Candidate profile Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Classes Mode Online or Remote Mode Interested Directly Please Contact - 9133469786

Educational Requirements Bachelor of Engineering,Bachelor Of Technology (Integrated),Bachelor Of Technology,Bachelor Of Science (Tech),Bachelor Of Commerce,Master Of Technology,MBA,Masters of Engg Science Service Line Enterprise Package Application Services Responsibilities A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domai...

Drive on 9th Nov - Officer (Packing Development Cell) Dahej | Pharma Preferred Diploma / BE / B.Tech – Packaging Technology 1–4 yrs exp | Artwork, GTIN, Vendor coordination, Packaging Dev Salary: Flexible

Join us as a Trade & Transaction Reporting Manager Well look to you to provide oversight on daily trade and transaction reporting processes, making sure that they adhere to the control framework and comply with regulatory obligations Youll provide input into regulatory reporting initiatives, through your expertise and knowledge of regulations, data analysis and issue remediation As a key member of our team, youll enjoy extensive collaboration and can expect great visibility for you and your work We're offering this role at vice president level What you'll do As a Trade & Transaction Reporting Manager, youll be operating a robust oversight model of trade and transaction submissions to support...

We have a suitable opening in the Quality Division for the role of Astt. Quality Manager , based at Silvassa & reporting to Pune Plant . You come with a relevant experience of 5-8 years . In this role, you will ensure its activities in managing operations linked to overall Loreal representative /receiving/ storage /QC analysis/ Product release/ shipping of finished goods in compliance with the objectives and the Group policy Job Responsibilities: Ensure implementation of L'Oral Quality system at contract manufacturing units. Ensure and monitor that core values of L'Oral quality Management system and EHS guidelines are adhered and respected in true spirit. Ensure RM, PM, Bulk and FG are contr...

JD for Production Chemist @ Production planning & oversight Process optimization Quality control Troubleshooting Compliance Documentation Collaboration Subsidized Sharing Accommodation, Meals & Transport from company All Saturdays will be Half day

Job Title: Sr Recruiter - (Healthcare Manufacturing/ Medical Device) Location: Vastrapur, Ahmedabad Shift Timings: 7:00 PM to 4:00 AM (U.S Shift) Mon - Fri 100% Onsite Role Experience Required: 1 4 years Job Summary: Specializes in recruiting for medical device design, engineering, quality, manufacturing, and regulatory roles. knowledge of GMP/FDA/ISO standards. About the Role: 14 years of full-cycle recruitment experience in medical device, healthcare, or pharmaceutical industries. Proven experience supporting clients such as Boston Scientific, Medtronic, DaVita, Abbott, Stryker, or similar. Strong understanding of GMP, FDA, and ISO 13485 environments. Proficiency with ATS systems (JobDiva,...

As an R&D Executive at PTC - MORAIYA, your role involves characterizing materials and developing/qualifying packaging systems, including primary, secondary, and tertiary packaging. You will be responsible for completing design control deliverables, supporting relevant regulatory requirements for submission, and providing post-launch troubleshooting support for complex products. Your tasks also include developing drug delivery devices like Pen Devices, Auto Injectors, DPI, and pMDI while ensuring a comprehensive understanding of regulatory expectations. Key Responsibilities: - Compile documents such as URS and design control/history file for combination products - Perform functional performan...

Role Overview: You will be designated as a Senior Executive - Quality (Audit and compliance) in the Corporate Quality department at Shalina Healthcare. Your main responsibility will be to conduct Vendor Quality Audits and ensure GMP and GLP compliance at various manufacturing and testing facilities. You will also be involved in preparing and presenting quality review meetings, conducting self-inspections, and coordinating with cross-functional teams for maintaining the quality system. Key Responsibilities: - Prepare and adhere to annual planner for Quality audits for Loan licence Units (LLU), Third Party Manufacturing Sites, public testing laboratories, and Shalina Operating units (OUs) - Re...

As a Process Equipment Engineer, you will be responsible for designing and specifying process equipment systems for pharmaceutical manufacturing plants. Your role will involve ensuring alignment with project goals and regulatory standards such as GMP, FDA, and EMA. Your key responsibilities will include: - Selecting appropriate equipment based on factors such as material compatibility, process requirements, automation, and cost-effectiveness. - Developing equipment specifications, datasheets, and technical documentation for procurement and installation. - Having hands-on experience in installing isolator-based filling lines from manufacturers such as Bausch + Straubel, Syntegon, and Sterilin...

As a Project Director for the Stem Cell Therapy project, you will be responsible for leading the program from lab to clinic, with a vision to guide the project from bench-to-bedside. Your role will involve coordinating cross-functional teams, including scientists, clinicians, regulatory, QA, and manufacturing staff. You will be expected to manage budgets, timelines, and risk mitigation plans effectively, ensuring the successful progression of the project. Key Responsibilities: - Lead or coordinate cross-functional teams involved in stem cell or regenerative medicine research - Manage budgets, timelines, and risk mitigation plans for the project - Work with internal and external stakeholders ...

As a Quality Assurance Specialist, you will be responsible for ensuring GMP and GLP compliance through various audit activities at Loan Licence Units (LLU), Third Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs). Your key responsibilities will include: - Preparation and adherence to annual planner for Quality audits to monitor overall performance and compliance. - Reviewing audit compliance reports for external/regulatory/customer audits and ensuring timely closure of observations. - Conducting self-inspections, compiling reports, and tracking compliance for timely closure. - Coordinating technical document evaluation from vendors, arranging sample an...

Job Title Mechanical Architect Job Description As a Mechanical Architect in our S&RC business unit, you will support remediation, relaunch (MLD), Sustenance and NPI activities and lead mechanical architecture and design for CPAP/BiPAP devices (Dream Station 1 & 2), driving product lifecycle activities including Modify Launched Design (MLD), PDLM, and CAPA. Collaborate across functions and suppliers to deliver robust, compliant, and innovative solutions. Key Responsibilities Lead design changes and MLD activities for Sleep therapy devices. Define and maintain modular, scalable mechanical architecture. Ensure safety, reliability, and performance compliance. Drive technical roadmap, feasibility...

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. He/she ensures each project is developed & released meeting customer expectations and regulatory requirements. The role is a key technical role that works closely with product engineering to ensure Design control Quality Management System Compliance for NPI and IB deli...

Identification of areas for improvement within operations and provide recommendations for change through the quality assurance process. Development and implementation of quality control procedures and controls to mitigate risks and maintain efficient operations. Collaboration with teams across the bank to develop quality improvement guidelines, initiatives, objectives, and action plans to monitor performance, improve business areas and govern processes. Development of reports and presentations on quality control performance and communicate findings to internal senior stakeholders. Monitoring of customer-facing colleagues performance, and evaluating their performance through reviews, quality ...

Your role and responsibilities As a Software Developer you'll participate in many aspects of the software development lifecycle, such as design, code implementation, testing, and support. You will create software that enables your clients' hybrid-cloud and AI journeys. Your primary responsibilities include Comprehensive Feature Development and Issue Resolution, Stakeholder Collaboration and Issue Resolution and Continuous Learning and Technology Integration Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise Installation, configuration and maintenance of JD Edwards EnterpriseOne environments including tools releases, ESUs, AS...

Responsibilities: Product Innovation & Technical Leadership Lead design and development of advanced orthopaedic implants and instruments, focusing on innovation, clinical performance, and patient outcomes. Identify clinical needs and market trends, and translate them into product requirements through interaction with surgeons and marketing teams. Provide technical leadership for concept development, design feasibility, and prototyping. Design Execution & Validation Develop 3D solid/surface models, detailed technical drawings, and design documentation using SolidWorks, AutoCAD, CREO software and CAM tools. Conduct and review FEA(Finite Element Analysis )/CAE (Computer-Aided Engineering) analy...