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What you will do:
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
What you need:
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-oriented
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers... Read more