679 Fda Jobs - Page 21

Support and Maintenance of customers Adobe Campaign Classic platform Responsible for handling tickets in Production environment Perform RCA on recurring issue and provide permanent fixes Monitoring of the workflow and taking corrective actions Coordination of system-related activities between user and multiple technical teams Responsible for the upkeep and maintenance of Adobe Campaign application servers and coordination with DBA's Understanding integration of Adobe with other applications. Primary Skills 4 to 5 years of support and development experience with Adobe Campaign Classic (Neolane) Experience in working with different Adobe Campaign modules, like; Message Centre, Content Manager,...

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, an...

Design and execute manual test plans, test cases, and exploratory tests across web and mobile platforms (React, Flutter). Validate regression, integration, UI/UX, and backend flows with deep attention to clinical user paths and edge cases. Maintain traceability from user stories to test artifacts , ensuring FDA audit readiness. Perform root cause analysis in collaboration with developers; help triage and verify defects in dev and staging. Review release readiness by participating in sprint ceremonies and QA sign-offs. Ensure test artifacts, screenshots, and logs are well-maintained in compliance with documentation standards . Must-Have Skills 35 years in manual testing with a strong track re...

Role & responsibilities : As a Regulatory Professional, the ideal candidate will be responsible to plan, prepare and submit high quality files to the authorities achieving fast approvals. The professional, act as an ambassador for assigned medical devices/device part of combination products. This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues. Preferred candidate profile

We are looking for a skilled Regulatory Engineer with 4 to 8 years of experience to join our team at Apptad Technologies Pvt Ltd. The ideal candidate will have a strong background in regulatory affairs and excellent analytical skills. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with industry standards. Collaborate with cross-functional teams to identify and mitigate regulatory risks. Conduct thorough analysis of regulatory requirements and develop effective solutions. Prepare and submit regulatory documents to relevant authorities. Monitor and report on regulatory changes that may impact the company. Provide training and guidance to internal stak...

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible Required Candidate profile RA role in medical device,US FDA,EU Bachelor degree in Medical,Mechanical,Electric Life Science/other healthcare related majors 8yrs exp for RA role in medical device/pharmaceutical industry

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningfu...

B.Pharm / M.Pharm with 8 to 10 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

B.Pharm / M.Pharm with 8 to 10 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

B.Pharm / M.Pharm with 8 to 10 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

B.Pharm / M.Pharm with 8 to 10 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

B.Pharm / M.Pharm with 8 to 10 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

B.Pharm / M.Pharm with 8 to 10 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

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier...

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketi...

As the Product Manager for the Cios Fit Platform, you will be the strategic and operational owner of a unique surgery product platform, which is the only one engineered and made in India in SHS. The Cios Fit is a value-segment medical imaging solution designed for intraoperative use across a range of clinical specialties, including orthopedics, surgery and urology. The product is exported from India to 30+ countries and developing the global footprint and expanding the product platform to new clinical applications is key for the success of the platform. You will lead the product strategy, define market and user requirements, drive execution in R&D and SCM aligned with business goals, clinica...

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS repor...

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

The Strategy & Consulting Global Network Song Practice| Service | Life Science Manager (Level 7) Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning Sales, Service and Marketing to accelerate business change. Practice: Strategy & Consulting Global Network Song I Areas of Work: Life Science, Service transformation, Contact Center, Platform Enablement viz. Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, etc | Level: Manager | Location: Bengaluru, Gurgaon, Mumbai, Chennai, Kolkata Hyderabad | Years of Exp:8 + years Explore an Exciting Career at Accenture Are you passionate about scaling businesses using in-depth frameworks and tec...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

: Job Title RDA&RR Independent Validation, Associate LocationMumbai, India Role Description The Basel Committee for Banking Supervision (BCBS) published a regulatory directive titled Principles for Effective Risk Data Aggregation and Risk Reporting in 2013, which DB and all other global systemically important banks (G-SIBs), must comply with. DB has defined a compliance framework that reinforces and strengthens practices in risk data aggregation and risk reporting - to improve the quality of information used for key risk decision-making, and ultimately to evidence compliance to the principles in BCBS 239 This role sits within NFRM which works in conjunction with the Divisional Risk and Finan...

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitt...

Lead and manage the QA/QC function at the plant level. Ensure compliance with FSSAI, HACCP, ISO 22000, and other relevant food safety and quality standards. Implement and maintain plant-level SOPs, SSOPs, GMP, and hygiene practices. Accessible workspace

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.