Regulatory Affairs Specialist, Russia & Kazakhstan
от 300 000 ₽
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- Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes in Stryker Russia & KZ.
- Provide maturity and significant RA experience and expertise to the EMEA regulatory team to accelerate market access.
- Ensure timely market access and regulatory compliance in Stryker Russia & KZ and build collaborative relationships with Russian regulatory bodies.
- Leads the execution and delivery of the registration plan for Russia & KZ and reviews product documentation in accordance with local regulatory requirements.
- File, maintain and organise local registration submissions and maintain regulatory flags in local ERP system.
- Primary contact with Russian Competent Authority on market clearance activities, ensuring ongoing market access in line with business strategy.
- Supports the execution of submission strategies and registration planning in Russia & KZ in collaboration with RA leadership.
- Reviews product change notifications issued by international manufacturing sites, evaluates re-notification requirements and communicates to EMEA regulatory team.
- Maintain active participation in product lifecycle management planning and associated regulatory execution.
- Build, implement and maintain effective local product registration processes.
- Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RA leadership.
- Provide regulatory guidance and training to EMEA RAQA colleagues, new starters and Design Divisions as a subject matter expert on Russian regulations.
- Monitor regulatory changes across Russia & KZ and escalate to RA leadership as necessary.
- Support the training of international Design Divisions in understanding registration requirements in Russia & KZ and design inputs for new product development.
- Provide support to the local Russian RAQA team and EMEA Regulatory team on various activities as appropriate.
- Support Corporate / International projects as required.
- Education / Work Experience:
- BS in Engineering, Science, or related degree; or MS in Regulatory Science.
- Typically a minimum of 2 years’ experience.
- MS or RAC(s) preferred.
- Knowledge / Competencies:
- Project management, writing, coordination, and execution of regulatory items.
- Perform technical and scientific regulatory activities.
- Usually works with minimum supervision, conferring with superior on unusual matters.
- Assignments are broad in nature, requiring originality and ingenuity.
- Has some latitude for unreviewed action or decision.
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