69 Cdsco Jobs

As a Product Manager at mlHealth 360 , you will lead the next phase of development for our AI-driven Radiology solutions, including medical imaging diagnostic AI products. The ideal candidate will combine technical acumen, clinical understanding, and regulatory awareness to drive end-to-end product lifecycle from concept to deployment and compliance with Indian SaMD regulations. Key Responsibilities 1. Product Strategy & Roadmap Define and own the product roadmap for AI-based radiology applications in CT, MRI, and X-ray domains. Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities. Collaborate with leadership to align product goals...

Role & responsibilities Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission a...

Hiring for a ManagerQARA for a leading medical device company Experience -5-12yrs Location -Delhi/NCR Job Profile -Responsible for leading Regulatory and Quality activities in the India Subcontinent geography- India and neighboring countries. responsible for driving regulatory process and strategy pertaining to registration of Company products in India Subcontinent geography & maintain data for registered products. He/she participates in all activities relating to preparation, compilation, submission of dossiers and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices. He/ she will be responsible for int...

1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...

Responsibilities: * Ensure compliance with regulatory requirements for medicaldevices * Oversee radiation safety protocols and training programs * Manage licensing processes for medical devices * M.Sc(Medical Physics, Radiation Physics, Life sci eng.

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Job Description JOB TITLE Project Manager REPORTING TO Nikita Bathla LOCATION New Delhi/Remote OPEN ENDED / FIXED TERM (Duration) Two-year appointment, extendable based on performance and institutional opportunities. FULLTIME EQUIVALENT 2.0 JOB FAMILY Projects CAREER STEP Independent About The George Institute We are a medical research institute affiliated with leading universities aiming to challenge the status quo in health care. With 700+ people around the world, and projects in over 40 countries, our Strategy 2025 is all about impact - specifically, the impact of The George Institute's activities on the health of millions of people, particularly those living in disadvantaged circumstance...

As a Clinical Research Physician (MBBS) at TruVita Wellness Inc., you will play a crucial role in clinically validating and enhancing the AI Doctor platform to ensure medical safety, ethical practices, and diagnostic accuracy. Your responsibilities will include: - Reviewing and validating AI-generated diagnostic outputs and treatment recommendations. - Supporting or leading clinical research studies to compare AI Doctor outcomes with human doctor diagnoses. - Designing study protocols, consent forms, and ethics committee submissions in collaboration with the Clinical Research Associate. - Supervising patient enrollment, data collection, and medical safety reporting in clinical validation tri...

Role & responsibilities Job Description: Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations. Key Responsibilities: Oversee submission, approval, and renewal of product licenses, manufacturing, and marketing authorizations. Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable regulations. Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters. Review and approve dossiers, product artworks, and labelling as per regulatory norms. Monitor changes in drug regulations and implement necessar...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Role Summary The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Dire...

Job Description: Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations. Key Responsibilities: • Oversee submission, approval, and renewal of product licenses, manufacturing, and marketing authorizations. • Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable regulations. • Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters. • Review and approve dossiers, product artworks, and labelling as per regulatory norms. • Monitor changes in drug regulations and implement necessary updates. • G...

1. Regulatory Affairs: - o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products. o Liaise with client and regulatory authorities for approvals, clarifications, and queries. o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products. 2. Toxicology & Safety Evaluation: o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports. o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies. o Maintain regulatory and toxico...

Company Description Elesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray and C-arm machines. By 2019, Elesonic expanded its operations to African Union through offices at Nigeria and Uganda. Same Year in 2019 Elesonic established a presence in Canada for Trans atlantic operation including Carribean Islands. Our pledge is to deliver quality and exceptional service in the industry. Join us in making the world a healthier place! Ro...

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...

Concept Medical is a leading developer and manufacturer of innovative medical devices specializing in interventional cardiology and radiology. Your role as a Regulatory Specialist will involve ensuring that our products comply with both local and international regulatory standards such as CDSCO, ISO, and FDA. Your expertise will be crucial in maintaining the highest levels of safety and efficacy for our stents and balloon catheters. Key Responsibilities: - Develop regulatory strategies for new and existing products to meet compliance requirements. - Ensure adherence to local and international regulations including CDSCO, ISO, and FDA. - Prepare and submit regulatory documentation and filings...

Position Title: RA Specialist III /IV (Senior RA Operation Specialist) Typically Reports to: RA Manager II Position Summary: What is the primary purpose of this position? Working with RA and co-ordinate with Logistics team (RA OGA) responsibilities includes but not least; released comply with import requirements and to support Port enquiries. Support RA Manager for product registration, Audits , DC Certifications and System Implementation and regulatory compliance Support India Import/Export inquiries at Ports along with OGA activities. Job Responsibilities 50% Manage India custom inquires related to licensing activities & OGA e.g. DCGI, BIS, MoeF, DoT, EPR e-Waste, Plastic waste and Battery...

You will be responsible for leading the development and finalization of key clinical trial documents with a focus on scientific accuracy, regulatory compliance, and clarity. Your role will require close collaboration with cross-functional teams to support the entire lifecycle of clinical documentation, from protocol development to submission-ready deliverables. Key Responsibilities - Lead the drafting and review of clinical trial protocols in coordination with medical, regulatory, and operational teams. - Prepare high-quality clinical documents such as Clinical Study Reports (CSRs), Investigators Brochures (IBs), Informed Consent Forms (ICFs), subject-facing materials, and study training doc...

Job Description Summary As Customs & Global Trade Team Leader , you will provide detail oriented and proactive support for international trade operations. This role ensures compliance with global customs regulations and supports smooth import/export processes for pharmaceutical products. Key responsibilities will include: 1. Team Management Effective in resource management skills, ability to synthesize disparate information, and build consensus, has sound judgment and decision-making Good interpersonal, leadership, and team player skills Excellent oral, written, presentation and communication skills Quality Orientation and ability to take initiative and demonstrate ownership of problem resol...

This is a full-time, on-site position based in New Delhi for a Regulatory Affairs Specialist. The role involves effective communication and coordination with both internal teams and external stakeholders to ensure regulatory compliance and smooth operational workflows. Key Responsibilities: Develop and implement procedures to ensure regulatory compliance across all functions. Lead the Regulatory and Quality departments by building systems, competencies, and structure. Keep up to date with evolving national and international regulations and guidelines. Ensure seamless coordination between Regulatory/Quality and other teams from product planning to government approvals. Manage timelines for va...

Job Description We are seeking a detail-oriented and proactive Trade Compliance & Operations Specialist to manage and oversee flow of import and export international shipments, ensure compliance with country global trade regulations & procedures, and coordinate with suppliers, freight forwarders, and customs agents. This position requires close coordination with cross-functional teams, service providers and regulatory bodies to mitigate risks, maintain documentation integrity, and uphold companys standards for ethical and compliant global commerce. The ideal candidate must have strong knowledge of import/export documentation, logistics, and international, country trade laws & regulations. Ke...

Role & responsibilities Responsible for ensuring and carrying out tasks in accordance with FDCA, CDSCO and Prohibition Excise guidelines. Responsible for preparing the ACDF application, i.e. CoPP, renewal and new manufacturing licences. Responsible for WHO GMP, Additional Product Permission, Tender Certificate, Test License Technical person approval Responsible for preparing wholesale license, loan license, audit, and inspection reports. Responsible for preparing IT application at CDSCO i.e. Test License, Form 10, From 11, Import & Export NOC Responsible to ensure and prepare renewal of licence for prohibition and excise. Also took necessary approval for Naukarnama and do return submission a...

Job Description We are seeking a detail-oriented and proactive Trade Compliance & Operations Specialist to manage and oversee flow of import and export international shipments, ensure compliance with country global trade regulations & procedures, and coordinate with suppliers, freight forwarders, and customs agents. This position requires close coordination with cross-functional teams, service providers and regulatory bodies to mitigate risks, maintain documentation integrity, and uphold company’s standards for ethical and compliant global commerce. The ideal candidate must have strong knowledge of import/export documentation, logistics, and international, country trade laws & regulations. K...

Responsible for supplier audit planning, scheduling, and conduct supplier audits. Responsible for vendor/ supplier quality and management issues. Responsible for implementation of ISO 13485 requirements Responsible for formulating, document, and maintain quality standards and ongoing quality objectives. -Analysis of raw material, In-process samples, and finished product. -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality. -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions to the R&D and Product Management team, also tracking the continuous improvement of the products. -Resp...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Position Sr Manager – Regulatory & Quality Assurance Experience – Min 10yrs Qualification – Graduate or Post Graduate (B.SC./M.Sc./M. Pharma) in Life Science / Chemistry. Location – Dhaulpur Salary – Negotiable In case interested kindly share your resume to hrcorporate@swearhealthcare.com OR Whats app – 8527517739 Roles & Responsibilities Responsible for implementation of Quality Management System as per ISO 13485:2016. Knowledge of BIS-ISI product registration & renewals. Understanding of UDI labeling requirements, UDI processes & Product Labeling to meet the GS1, ISO 15223-1, EN 62366, ISO 20417, and EU MDR 2017/745 requirements, etc. Knowledge of barcode symbology (GS1 barcodes, & QR code...