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RA Associate Manager Job

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Date: Feb 11, 2019

Location: Beijing, 11, CN, 0

Company: Boston Scientific

Purpose

  • Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrationsn++ 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 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.
  • Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
  • Lobby the local health authorities using constructive/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.
  • Supports tender operations by timely supply of accurate regulatory documents.
  • Establishes relationships with local medical device industry groups and works with industry peers to lobby 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 a complete understanding and wide application of principle, theories, and concepts in the field. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.
  • Problem Solving: Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
  • Planning and Organization: Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
  • Discretion/Latitude; Supervision Received; Decision Making: Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting ...

BSC


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