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Sr Regulatory Affairs Specialist, Northern Europe Job

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Date: Nov 28, 2018

Location: Hemel Hempstead, HRT, GB

Company: Boston Scientific

Purpose

 

Within the Europe Middle East & Africa (EMEA) Regulatory Affairs organization, the main objectives of the role will be to contribute to successful regional business goals by supporting day to day regulatory activities in the Northern Europe region, in direct interaction with local regulatory authorities, with a focus on post-market surveillance activities, regulatory support to cross-functional and divisional business units and regional advocacy efforts, this for the entire Boston Scientific product portfolio.

 

Responsibilities

 

  • Establish, manage and maintain good relationships with the local regulatory authorities in the region
  • Interacts directly with regulatory authorities personnel and coordinate post-market surveillance activities, for all buisness units.
  • In direct interaction with the business divisions, support the preparation, conduct and follow-up of regulatory authorities meetings on post-maket surveillance matters.
  • Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on vigilance and other post-market. surveillance matters in the region.
  • Manage and execute regulatory-related activities associated with field safety corrective actions initiated in the region.
  • Provides input and data on regulatory-related issues associated with compliance and achievement of the business plan in the region.
  • Plan, execute and maintain product registrations with regulatory authorities for his/her respective product lines, in accordance with product launch plans, as applicable in the region.
  • Review and approve promotional and advertising materials in compliance with BSC Corporate policy and applicable national regulations.
  • Support tender operations and business units by timely supply of acurate regulatory documentation and informaiton
  • In collaboration with cross-functional project teams, plan, prepare and submit applications for clinical investigations to regulaotry authorities in the region, and coordinate responses to questions.
  • Support regulatory advocacy activities in the region and local medical devices industry working groups.
  • Establish and maintain a good working relationship with regional regulatory afffairs, cross-functional peers and business units to gain positive & timely support.
  • Serve as regulatory consultant to marketing and government teams as required.
  • Complete the mandatory Quality training subject to the defined timeline.  And ensure compliance with internal Quality system and policy.

 

 

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 

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.
  • Business Relationships and Project Management: Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
  • Impact: Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
  • Liaison: Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between
  • Mentoring: Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

 

 

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