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Boston Scientific Regulatory Affairs Manager - Andean 
Colombia, Bogota 
681414867

28.06.2024

Key Responsibilities

  • Participate and advocate with external industry groups to implement regulations that benefit the industry and public health.
  • Develop and incentivize alternative regulatory strategies to benefit the business.
  • Manage organizational structure of the for-process efficiency.
  • Develop and implement plans for professional development of the team.
  • Ensure regulatory strategies are implemented to maintain compliance with domestic and regional regulatory requirements.
  • Advise cross-functional teams on regulatory requirements and assist with the interpretation and implementation of regulations.
  • Manage the RA team to optimize the preparations of regulatory dossiers aligned with the commercial strategy.
  • Ensure the team efficiently prepares for regulatory assessments for changes in existing products.
  • Maintain awareness of changes in regulatory requirements and industry trends that could impact the organization.
  • Build strong relationships and advocacy with regulatory authorities and participate in meetings and negotiations.

Required Qualifications

  • At least 5 years of management experience
  • Minimum of 10 years of experience in regulatory affairs in medical devices or pharmaceutical industry.
  • Expert knowledge of INVIMA regulations, guidelines, and requirements. Knowledge of other international regulatory requirements is a plus.
  • Strong communication, organizational, and team management skills.
  • Experience with management of complex teams.
  • Ability to orient and mentor the professional development of their team.
  • Ability to work in a fast-paced environment with changing priorities and tight timelines.

Preferred Qualifications

  • Bachelor's degree in life sciences, engineering or related field required; advanced degree preferred.
  • Strong relationships with industry associations and evidence of influencing / leading regulation changes.
  • Experience presenting business cases for projects and leading their execution.
  • Experience leading and working collaboratively with cross-functional teams.