Regulatory Affairs Specialist, Russia & Kazakhstan

Responsibilities:

• 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.

Qualifications:

• 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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