Regulatory Affairs Specialist

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...

The Regulatory Affairs Associate will manage the preparation, review, and submission of regulatory documents to ensure compliance with applicable regulations. The role will involve monitoring adherence to regulatory requirements, staying updated on relevant guidelines, and providing strategic input on regulatory matters.QualificationsKnowledge of Regulatory...

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...

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...

Company:ELT Corporate Pvt. Ltd.Location:Rohini, Delhi (on-site)Experience:1–3 YearsEmployment Type:Full-TimeCompany DescriptionELT Corporate Pvt. Ltd. is a leading regulatory affairs and compliance consulting firm offering end-to-end services in BIS certification, NABL accreditation, CDSCO registration, EPR authorization, WPC license, and FDA regulatory...

 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...

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...