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Specialist, Reg Affairs Job

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Date: Dec 19, 2018

Location: Buenos Aires, C, AR

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 developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
  • Problem Solving: Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.
  • Planning and Organization: Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Discretion/Latitude; Supervision Received; Decision Making: Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.
  • Business Relationships and Project Management: Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.
  • What we are looking for:

  • A Professional or student of the last year of Bioengineering, Pharmacy, Biochemistry, or Biological Sciences only.
  • Proficiency in the English language both oral and written (excluding).
  • Experience in regulatory affairs, preferably medical devices, pharma or Senasa
  •  

    Personal characteristics:

    • Be a team worker

    • Ability to make decisions and solve problems.

    • Capacity to work under pressure.

    • Ability to interact with the health authority

    • Interpersonal skills: proactivity and initiative, responsibility, cordiality.

    • Commitment

    • Experience in presentations

    • Reside in the city of Buenos Aires or GBA

 

Regulatory Specialist


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