Medical Device Regulatory Affairs Manager

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...

The primary role for the Regulatory Affairs Specialist is to manage end to end Regulatory Submissions & Compliance for Masimo India teamPrepare, draft, and compile 510(k)/any other applicable Premarket Notifications and related FDA submissions.Support domestic and international product filings and registrations, including maintenance of EU Technical Files,...

DescriptionJob Summary : Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, domestic regulatory clearances for Masimo's amazing innovative products. The individual will be the sole RA representative on various project teams for new products.  For each project, the individual will provide regulatory input on,...

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...

 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...

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...

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,...

We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR).Key Accountabilities:Technical Compliances, Accreditation Requirements and collaborating with a Team...

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...

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...