Обязанности:
Responsibilities: Managing full cycle of medical devices registration - preparation, filing and registration dossier for the registration on the market in accordance with country’s legislation and standards - primarily Kazakhstan, but may be assigned to registration projects in Russia based on organizational needs and priorities Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes Negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Assists other departments in the development of SOPs to ensure regulatory compliance Provides regulatory input and technical guidance on global regulatory requirements to product development teams Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process Provides regulatory information and guidance for proposed product claims/labeling Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines Monitors the progress of the regulatory authority review process through appropriate communications with the agency Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees Attends local RA and QA Audits Requirements: Degree in a relevant field Minimum of 2 years’ experience in Kazakh and Russian registration Experience in EEU registration is desirable Fluent in Russian with a good command of English Knowledge of the Kazakh language is desirable Experience in project management, writing, coordination, and execution of regulatory items Proficient user of MS Office, including Word, Excel, and PowerPoint Good communication skills, both written and verbal Ability to work independently with minimal supervision, consulting with superiors on unusual matters Results-orientedПохожие вакансии
Специалист по регистрации медицинских изделий / Regulatory affairs specialist (Medical devices)
Договорная
Москва
Manpower