1524 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 ...

Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...

JD For QARA                                                Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking).  Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance:  Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with ...

Designation : RA Specialist Location - BKC Experience: 4.0 Year(s) To 10.0 Year(s) Work Time -  9 AM to 5 PM Work Days - Monday to Friday (Saturday and Sunday off) Salary – Best in Industry, Other benefits- PF, Mediclaim, bonus,24 days paid leaves and Bus Facility. It will be on role of Talisman HR Solutions Pvt Ltd payroll and on 1 ...

For a role that encompasses IT GRC (Governance, Risk, and Compliance) along with IT Security Auditresponsibilities, especially in the context of NIST, ISO 27001, SOC2, ITGC audit, RBI (Reserve Bank of India)regulatory compliance, IT Security Compliance, Business Continuity Management (BCM), Disaster Recovery(DR), and Vulnerability Assessment (VA), the roles and responsibilities ...

Description : Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance: Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish quality control ...

    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 ...

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 & ...

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 ...