65 Job openings found

POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent engineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA: • Provide quality and regulatory affairs input to the productdevelopment team and handle all QA & RA responsibilitiesthroughout product development, design change and post marketsurveillance process• As ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

An Assistant General Manager (AGM) of Liaison serves as the vital go-between linking the company, government entities, and the public. They drive regulatory compliance, secure statutory approvals, and manage critical external relationships to ensure smooth operational functionality and project execution.  Key Responsibilities Government Relations: Develop and execute liaison strategies with local, state, ...

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

Job Description:           To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.  ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines ...

Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...

Regulatory Affairs Executive – Medical DevicesExperienced Regulatory Affairs Executive with strong expertise in Medical Writing, EU MDR 2017/745 compliance, and regulatory documentation for Class IIb & Class III Implantable Intra Ocular Lens (IOL) devices. Skilled in handling Clinical Evaluation documentation, Technical Files, Risk Management, Post-Market Surveillance, and QMS documentation in ...

An AGM/DGM Liaison role involves being the key link between a company and government bodies, regulatory authorities, and other external stakeholders, focusing on securing timely project approvals (like NOCs, CC, OC), ensuring statutory compliance (RERA, DTCP, MOEF), managing land acquisition, and resolving issues for smooth project execution, often in real estate, infrastructure, or ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...