Regulatory Affairs Manager

Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

Job Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended for Rest of the World (RoW) markets, ensuring compliance with country-specific...

Regulatory SpecialistWe are seeking a dedicated and knowledgeable Regulatory Specialist to join our team. This role is responsible for ensuring our medical devices meet local and international regulatory standards.The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety...

Regulatory Compliance Specialist RoleThe ideal candidate will be responsible for ensuring our medical devices meet local and international regulatory standards.Develop strategic approaches to regulatory compliance for new/existing products.Verify adherence to local/international regulations (CDSCO, ISO, FDA).Prepare and submit comprehensive regulatory...

About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

Lead Food Regulatory Affairs ExpertWe are seeking a highly skilled and motivated individual to drive policy initiatives, engage with industry stakeholders, generate revenue, and organize impactful initiatives in the Food Regulatory Affairs domain.Job Overview:As a Lead Food Regulatory Affairs Expert, you will be responsible for analyzing food regulations,...

**Job Title:** Senior Regulatory Affairs Specialist About the Role:We are seeking a seasoned professional to lead and manage CMC regulatory activities for USFDA submissions. As our ideal candidate, you will be responsible for overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses. Main Responsibilities:Lead and...

Job Summary:We are seeking a skilled Regulatory Affairs specialist to support our end-to-end submissions for global markets.This role requires the ability to manage lifecycle management, Veeva Vault RIM, and complex initial and variation submissions.Main Responsibilities:Prepare Variation documents and evaluate post-approval CMC changes in compliance with...

Job Summary:We are seeking an experienced Regulatory Affairs Specialist to lead our CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.Manage and coordinate the compilation and submission of Annual Reports, amendments, and deficiency responses.Collaborate with cross-functional teams, including Quality Assurance,...

About us, we are at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare drives us to provide best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team to further our mission of saving lives and...