Regulatory Affairs Manager

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Boston Scientific Corporation A tiempo completo

Work mode:
Hybrid
Onsite Location(s):Bogota, CO
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

  • At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and highperforming employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.
    About the role
The RA Manager Andean will lead a team of RA experts with complex projects.

This role will work collaboratively with the business to seek efficiencies in the current team ́s operation, challenge the team to look for alternative regulatory strategies and work hand in hand with the business as a whole.

The manager will orient, mentor and develop the team for professional growth and further business impact.

In addition, this role will coordinate to position BSC as a key influencer in industry groups and drive positive change.


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 forprocess 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 crossfunctional 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.

What we are looking for
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 fastpaced 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 crossfunctional teams.

Requisition ID:

Job Segment:Regulatory Affairs, Compliance, Pharmaceutical, Law, Medical Device, Legal, Science, Healthcare

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