Regulatory Affairs Specialist For Medical Devices

We are HiringRegulatory Affairs Specialist For Medical Devices(OrthopedicImplants And Instruments)Role & Responsibilities:Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.Work On Technical Master File.Work On CERs (Clinical Evaluation Report) As Per EU MDR.Work on Design & Development and Risk Management Files as per EU MDR.Have...

We are Hiring QA/Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments)Role & Responsibilities:Documents preparation for ISO13485, CE Certificate (As per EU MDR).Work on technical master file.Work on CERs (clinical evaluation report) as per EU MDR.Have knowledge about QMS (quality management systems).Reporting to regulatory...

BIOTEK is a global medical device company focusing on new product development in the most advanced Orthopaedic sector: SPORTS MEDICINE. With presence on all six continents worldwide, the growth and demand for our products around the globe is unprecedented.As a Regulatory Affairs Sr. Coordinator, you'll play a crucial role in regulatory submissions for...

Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company that was founded by a visionary team of highly successful individuals in the field of pharmaceuticals. The company is dedicated to providing high-quality healthcare products and services globally. CLAPS is expanding rapidly through product diversification, strategic...

Job Purpose:To lead regulatory submissions and compliance activities for cardiovascular medical devices, specifically drug‑eluting stents, balloon catheters, and related vascular devices. Ensure adherence to Indian Medical Device Rules (MDR 2017), ISO 13485, and EU MDR.Key Responsibilities:• Prepare and submit regulatory applications for stents and...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

Job Title:Regulatory Affairs Executive – Regulatory & Safety (Radiology & Imaging Systems)Department:Regulatory & Safety – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – Regulatory & SafetyJob Purpose:To manage and coordinate regulatory documentation and compliance activities for radiology and imaging systems such as...

**Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...

Job Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools...

Company DescriptionBiotek Ortho is a global medical device company specializing in cutting-edge innovation within the orthopedic sector, particularly in sports medicine and extremities. With a strong presence across six continents, Biotek continues to experience robust growth and demand for its high-quality products. Despite its global reach, Biotek remains...