Medical Device Regulatory Affairs Manager

Hiring Now: Executive Regulatory Affairs Are you ready to take your career to the next level in regulatory affairs?Join our team and play a pivotal role in ensuring compliance and excellence in the medical device secto Key Responsibilities:-Prepare and review CTD, ACTD, and TCF dossiers with precision.-Review critical technical documents such as:-Process...

Zoot Systems is a New Delhi, India based company. For years, it has been our continuous endeavours to understand Client quality-conscious discerning business needs and to successfully meet those. We specialize in the creation of high-quality I.T./Non-I.T. based HR Solutions, Recruitment, and RPO to companies of all sizes resulting in better, faster, and more...

 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...

Job Title: Quality Assurance (QA) ManagerLocation:Sector 11, Noida, Uttar PradeshExperience Required:5–10 yearsIndustry:In-Vitro Diagnostics (IVD) / Medical Device ManufacturingAbout Avience Biomedicals LimitedAvience Biomedicals Limited has over 20 years of experience in molecular biotechnology, genomics and the IVD industry. We are among the leading...

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...

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...

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...

We are seeking an experienced Production Executive to oversee manufacturing operations, ensure compliance, drive efficiency in medical device production. Ideal candidate will have a blend of technical expertise, leadership,regulatory knowledge Required Candidate profileProduction OversightCompliance & RegulatoryProcess ImprovementdocumentationKnowledge of...