2361 Job openings found

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 Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

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 ...

  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 ...

Managing the process of obtaining grid connectivity for renewable energy projects. This includes coordinating with various stakeholders, navigating regulatory frameworks, and ensuring compliance with technical specifications. The role requires a strong understanding of transmission infrastructure, renewable energy technologies, and project management principles.    Here's a more detailed breakdown of the job description: Key Responsibilities: Connectivity Application ...

We are seeking a seasoned Information Security professional who has expertise in GRC with over 8+ years of progressive experience across data security, access management, IT security, network security, IT risk management, and compliance with standards such as ISO 27001, HIPAA, GDPR, NIST. This individual will lead GRC efforts, ensuring ...

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 INTENT The position responsibilities would include ensuring compliance with SEBI Mutual Fund, PMS and AIF Regulations while also handling queries from internal departments and regulators and managing coordination for internal meetings. JOB RESPONSIBILITIES Making/vetting SID of all new schemes and updating SAI Product vetting /Product compliance related tasks Vetting of marketing material /advertisements. Preparation and ...

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 ...

Job description for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...

We are seeking a proactive and well-connected Liaisoning Officer to manage and facilitate communication between our organization and government departments, regulatory agencies, and other external stakeholders. The candidate will be responsible for ensuring smooth coordination for obtaining approvals, licenses, and clearances necessary for the company’s operations. Key Responsibilities: ✅ Government & Regulatory ...