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Principal RA Specialist Job

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Date: Aug 21, 2019

Location: Kangnam-gu, 11, KR

Company: Boston Scientific

Purpose

 

  • Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.  Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team with regular updates on product registration and new regulations from government body.
     
    Responsibilities
     
  • Provides input on regulatory-related issues associated with compliance and achieving the business plan.
  • Prioritize and plan on product registration including KGMP certification for his/her respective product lines.
  • Preparing, coordinating and submitting regulatory applications to the local health authority.
  • Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration.
  • Ensure product registrations are reviewed and renewed as required.
  • Monitor diligently regulation changes and share the changes with internal stakeholders timely.
  • Participate in RA related global projects and lead local RA projects.
  • Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
  • Build a constructive relationship with local health authorities through quality submission, active cooperation on any MFDS requests and scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
  • Supports tender operations by timely supply of accurate regulatory documents.
  • Establishes relationships with local medical device industry groups and works with industry peers to respond accordingly to the Competent Authorities in matters of regulatory issues and to influence local policies.
  • Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
  • Serves as regulatory consultant to marketing team and government regulatory agencies.
  • Complete the mandatory Quality training subject to the defined timeline.  And ensure compliance with internal Quality system and policy.
     
    Management Requirements
     
  • Not applicable.
     
    Job Scope and Leveling Guidelines
     
    Knowledge: A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.
     
    Problem Solving: Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
     
    Planning and Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
     
    Decision Making: Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental ...
     
    Business Relationships and Project Management : Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources.  Provides leadership to business units.
     
    Impact : Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.
     
    Liaison : Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.
     
    Mentoring : Participates in the development of others by facilitating training and providing feedback and guidance.
     
     

Other Requirement

- University graduate, with a minimum 8 year RA experiences

- Working experience at MNC medical devices company preferrable 

- Excellent communication skill both in Korean and English


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