Regulatory Affairs Specialist – BIS

Strong knowledge of regulatory affairs principles, regulations, and guidelines, particularly in the relevant industry.Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.Provide regulatory guidance and support to internal stakeholders, including product...

Company DescriptionAce Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7...

Experience:1-2 YearsLocation:Rohini Sector-3, New DelhiCompany:ELT Corporate Private LimitedCompany DescriptionELT Corporate Private Limited is India's leading regulatory and market-access consulting company, assisting manufacturers, importers, and exporters in obtaining statutory certifications such as BIS, Legal Metrology, CDSCO, CE,USFDA,EPR, and AEO....

EXECUTIVE -REGULATORY AFFAIRS Export Regulatory Affairs will be responsible for managing and coordinating regulatory submissions, product registrations, and compliance activities for international markets. This role ensures that all documentation and submissions meet the regulatory standards and timelines of target export countries, while supporting business...

 Experience in medical device regulatory document preparation including Clinical Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up Plan/Report, Periodic Safety Update Report (PSUR) for Medical devices, Summary of Safety and Clinical Performance (SSCP) Report etc. Skilled in Materiovigilance activities and reporting in...

About WebcardioWebcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.Role OverviewThe Medical Affairs Manager will lead and oversee...

Experience Required: 4-6 yearsJob DescriptionA SQL Power BI specialist is required to work for a leading provider of business collaboration solutions. The Power BI Specialist will design, build and deploy business intelligence reports and dashboards using Microsoft Power BI.Key Accountabilities:Develop operational reports such as dealing and financial system...

Job Description:New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.Approval : Review & prepare response to deficiency enabling...

Prepare and submit regulatory submissions, including product registrations, variations, renewals, and licenses to various Authorities in different countries. Apply and manage CDSCO licenses (e.g., ISO 13485, MDR 2017/745, US FDA, etc.). Required Candidate profileExcellent written and verbal communication skills with the ability to produce high quality...

Position:DM / MGRFunction:Corporate Affairs (CPA)Experience:~3-7 years (preferably in the auto industry)Location:Maruti Suzuki Head Office, Vasant KunjRole Overview:We are looking for a dynamic, sharp, and self-driven professional to join our growing Corporate Affairs team. The role involves translating complex automotive policy issues into clear, compelling...