RA Specialist based in Russia & KZ in Moscow at Stryker Corporation

Date Posted: 11/28/2019

Job Snapshot

Job Description

The Job’s Mission

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Key Activities & Accountabilities

  • 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

  • Degree – Medical/Life Sciences/Engineering

Experience

  • 2 years industry experience

Work From Home: Not available

Travel Percentage: 10%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team