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QA & RA Specialist Principal (Bogotá) Job

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Date: Nov 20, 2020

Location: Bogota, CUN, CO

Company: Boston Scientific

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer
 

Purpose

 

  • The purpose of this role is to provide Quality and Regulatory expertise to support to the local/region/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement. There are two primary roles: 1) critical in ensuring rapid and timely approvals for respective product lines including the management of all product registrations and provides management team with regular updates on product registration and new regulations from government body competent authorities/health authorities; and/or 2) ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.

 

Responsibilities

 

  • Regulatory Affairs Responsibilities: Prioritize, plan and execute on product registration andre-certifications for his/her respective product lines; 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; Establish and maintain a good working relationship with regional and divisional RA peers to gain positive & timely support for document preparation, submission and approval; Serves as regulatory consultant to marketing team and government regulatory agencies, Communicates with competent authorities on field corrective actions, vigilance etc.
  • Quality Assurance Responsibilities: Maintains, advises and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site; Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory/compliance oriented initiatives; Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement; May verify implementation of suggested solutions; Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior; Frequently interacts with and represents the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.g. Complaint reporting, Field Action execution, etc) - May also interact with national regulatory authorities; 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.

 

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.
  • 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. Develops departmental policies and procedures, new techniques and standards.  
  • Business Relationships and Project Management: Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Provides leadership to business units.
  • Mentoring: Participates in the development of others by facilitating training and providing feedback and guidance.
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What we are looking for:

 

  • Professional in Pharmaceutical Chemistry, Chemical Engineering or related degrees.
  • <span style="font-family:"Calibri",sans-serif">Minimum 5 years of experience in Regulatory Affairs and/or Quality Assurance in any industry.  Preferably Health care: Regulatory dossiers preparation; Knowledge in local Medical Devices regulation, Management of non-conformances and CAPA, Internal and External audits management.
  • <span style="font-family:"Calibri",sans-serif">Previous participation on Industry Associations is desirable
  • <span style="font-family:"Calibri",sans-serif">Project management / Agile methodologies knowledge is desirable.
  • <span style="font-family:"Calibri",sans-serif">English Level:  B2 or above (equivalent)
  • <span style="font-family:"Calibri",sans-serif">Advanced level in Excel

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose -- improving lives through your life’s work


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