669 Fda Jobs - Page 8

Experience At least 10 years IT experience with recent focus around J.D. Edwards EnterpriseOne (preferably 9.1 version) in technical development tools for customization, retrofit, data conversion and interface development OMW, RDA, TDA, FDA, Visual Compare, FRW, TCs, BI Publisher BSFN and BSSV, Orchestrator, Groovy Scripts, will be an added advantage. Role Consultant should have a minimum of one full-cycle implementation or upgrade experience of EnterpriseOne, he/she should have played a sizeable role in one of the technical streams of Global JD Edwards project along with : Proven experience and understanding of various JD Edwards technology options around customization, retrofit, data conve...

Experience: 8+ Years Job Location: Remote Work Timings: 1:30 PM to 10:30 PM IST Title: Software Quality & Compliance Manager We are seeking an experienced Software Quality & Compliance Manager with 8+ years of expertise in regulated PMA environments. This role blends project leadership, regulatory oversight, and quality assurance, ensuring that all deliverables align with stringent compliance standards. Key Responsibilities FDA Compliance Experience in securing and maintaining FDA approvals for software products in regulated environments. Strong knowledge of the FDA approval lifecycle, including preparation, documentation, submission, and compliance monitoring. Proven ability to collaborate ...

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain So...

SUMMARY Senior iOS Developer Build Mission-Critical Health-Tech Apps (On-site only) Company: Ajmera Infotech Private Limited (AIPL) Location: Ahmedabad, Bangalore/Bengaluru, Hyderabad (On-site) Experience: 4 8 years Position Type: Full-time, Permanent Shape Mobile Experiences That Save Lives AIPL’s 120-engineer team powers planet-scale systems for global innovators. We are assembling a specialised iOS squad to build FDA-compliant, SwiftUI -first apps for a billion-dollar health-tech platform (client name confidential). Your code will run on iPhones and iPads used daily by clinicians and patients worldwide software that simply cannot fail. What Makes This Role Exciting Greenfield + Legacy mod...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

Manage daily operations of regulatory function of the assigned category Liaise with a range of colleagues from Marketing, R&D, supply, and global/regional regulatory teams. Maintain Regulatory Databases Review, interpret and assess impact of the regulatory changes. To manage compliance activities for Sustainability under Plastic waste management, Battery waste management and E-waste management rules across Reckitt entities & portfolio Preparation, maintenance and update of product registration/license and regulatory compliance files. Compilation of registration dossiers for submissions to authorities Coordination with central and state regulatory authorities/ FDAs for necessary product appro...

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation or dossier as applicable for the product registration and the certifications. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applica...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role Objective A key objective of this position is to serve as a strategic leader by providing scientific, technical, and managerial expertise in Quality Control (QC) and Analytical Development across diverse product portfolios. The position is responsible for establishing, validating, and implementing robust analytical testing methodologies in alignment with global regulatory requirements. In addition, the role emphasizes driving operational excellence, ensuring regulatory compliance, and fostering a culture of continuous improvement within the organization. Desired Candidate Profile Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, or a related field. Minimum 1822 years of r...

To assist the Finance Department in ensuring accurate and timely execution of payments, management of daily cash flows, vendor reconciliation, and financial documentation related to accounts payable and cash transactions. The Junior Finance Associate plays a crucial role in maintaining financial control and ensuring operational efficiency within the finance function of a global shipping business. Role & responsibilities: Monitor daily bank balances and cash positions. Assist in preparing daily and weekly cash flow reports. Coordinate with banks for fund transfers, forex settlements, and related documentation. Support treasury operations, including updating bank mandates, KYC compliance, and ...

We are seeking a highly experienced and driven Global Process Owner to lead the transformation of our Order to Cash (O2C) processes within our finance and accounting function. The successful candidate will be responsible for driving the analysis, design, and implementation of process improvements across multiple business divisions and regions, including the Americas, EMEA, and APAC. This role requires a strong leader who can influence, and impact work delivered from multiple centers across US and Chennai, India, and collaborate with multiple senior stakeholders at the client end. Lead the transformation of the O2C process, focusing on optimizing efficiency, reducing costs, and enhancing cust...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Roles and Responsibilities Lead and manage CAPA process from initiation to closure. Coordinate root cause investigations and ensure robust corrective actions. Track and report CAPA metrics and trends to management. Drive quality improvement projects and cross-functional collaboration. Ensure timely documentation and regulatory compliance. Facilitate audits and provide CAPA-related evidence. Support risk management and preventive action initiatives. Qualifications Bachelor’s degree in Engineering, Mechanical or related field. 7+ years’ experience in Quality/Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project ma...

B.Pharm / M.Pharm with 2 to 6 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Purpose of the role: The Design Lead will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and...

Role Description Implementing quality control and assurance processes ensure compliance with regulatory standards ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment. Health insurance Annual bonus Provident fund

Job Description Tiger Analytics is a global AI and analytics consulting firm. With data and technology at the core of our solutions, our 4000+ tribe is solving problems that eventually impact the lives of millions globally. Our culture is modeled around expertise and respect with a team first mindset. Headquartered in Silicon Valley, you'll find our delivery centers across the globe and offices in multiple cities across India, the US, UK, Canada, and Singapore, including a substantial remote global workforce. We're Great Place to Work-Certified. Working at Tiger Analytics, you'll be at the heart of an AI revolution. You'll work with teams that push the boundaries of what is possible and buil...

Job Title: Manager Exports Department: International Business / Exports Reporting To: Head Exports Location: Pune Key Responsibilities Develop and manage export sales strategy for assigned regions. Build and maintain strong relationships with QSR clients (Pizza Hut, Domino's, KFC, Subway, Burger King, etc.) and international distributors. Liaise with Purchase Managers, Quality Assurance Managers, and Supply Chain teams of QSR chains to ensure product approvals, compliance, and smooth supply. Drive business development initiatives to increase sales of condiment products (sauces, dips, spreads, seasonings, etc.). Negotiate contracts, pricing, and trade terms with international buyers. Ensure c...

The Analyst will support pharma-focused mystery shopping assignments to ensure compliance with prescription verification, OTC handling, healthcare privacy laws, and payment card brand requirements (Visa VIRP, MasterCard BRAM, Amex/Discover HBR). This is an entry- to mid-level role requiring 13 years of experience or internship exposure in healthcare compliance, risk management, or related fields. Key Responsibilities Assist Senior Consultants in conducting pharma-focused secret shopping assignments. Simulate real-world transactions including prescription verification, OTC purchases, and pharmacist consultation. Document findings with evidence such as screenshots, notes, and test transactions...

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

Role #1 : Test Manager- Portals, Mobile app Location : Chennai, Bangalore, Hyderabad Individual to drive the Test strategy , test automation and introduction of software and mobile apps for cutting-edge medical devices. This role demands deep technical expertise in web portals, Mobile test automation, regulatory compliance, and cross-functional leadership to ensure successful product launches in a highly regulated environment. Key Responsibilities: Lead end-to-end NPD/Sustenance activities for Portal and Mobile app testing in medical devices. Oversee Test protocols, test strategy and test automation testing aligned with IEC 62304 standards. Manage and troubleshoot communication protocols inc...

Gather and influence eCOA design specifications from Clinical Trial Protocol to enable successful trial design and implementation As a Clinical database programmer, build, program and test Clinical trial data collection systems (eCOA database) and associated data repository mappings for a trial or set of trials within a program using data standards library components Ensure Clinical data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives Partner with translation vendors to implement localized data collection in country specific language Partner with Clinical Build Programmer to ensure complete data build for trial data ...

Your Role Take overall responsibility and project manage the implementation of travel products for clients. Document and track projects using client-specific processes and tools. Act as the single point of contact for the project team throughout the implementation process. Ensure adherence to the client-defined onboarding process, from pre-assessment to post-implementation. Lead local Joint Planning meetings and ensure effective collaboration. Clarify and communicate roles and responsibilities to all project members. Lead weekly conference calls, prepare agendas, and produce detailed call notes. Monitor project progress, ensure timely completion of tasks, and update project tracking tools (e...

Role Overview: As a Regulatory Compliance Manager at CareNX, located in Mumbai, you will play a crucial role in ensuring the company's adherence to regulatory requirements and standards. Your responsibilities will include monitoring and analyzing regulatory changes, managing regulatory affairs, and ensuring compliance in all operational activities. You will collaborate closely with the finance team to guarantee regulatory compliance in financial practices. Key Responsibilities: - Monitor and analyze regulatory changes relevant to the healthcare industry - Manage regulatory affairs to ensure adherence to standards like ISO13485, IEC, CDSCO, CE, and FDA - Ensure compliance in all operational a...