86 Job openings found

Job Overview: The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document ...

Key Responsibilities: Regulatory Compliance Management: Oversee and manage the company's compliance with local and international regulatory requirements (e.g., SEBI, RBI, AMFI, etc.). Monitor changes in the regulatory environment and ensure the business adapts accordingly. Conduct periodic reviews to ensure all processes and activities align with the latest regulatory guidelines. Risk Management: Assess risks associated with the ...

    Regulatory Affairs Officer (RA) Qualification: B.Pharm/ M.Pharm Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience. Job Description: Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA. Bond: 18-month ...

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 ...

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

Responsibilities: Audit Planning and Execution: Plan and execute comprehensive audits of banks and NBFCs in accordance with auditing standards and regulatory requirements. Conduct risk assessment and develop audit programs to address key audit risks and objectives. Perform detailed testing of financial transactions, controls, and processes to ensure accuracy and compliance. A strong eye for detail ...

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 ...

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 Description & Specification Job title Company Secretary Date 6/15/2024 Function Secretarial Location Mumbai Designation Company Secretary Job Grade   Reporting to (position) Chief Financial Officer Direct Reportees (Nos) 0 Position Code -  Company Name - Alchemie Finchem Limited Key Role & Responsibilities * Indepeent handling of complete secreterial compliance at a company level and handling secreterial audit           • Advising the board and senior management on compliance matters and best practices. • ...

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, ...