Boston Scientific Regulatory Affairs Manager - Andean 

Colombia, Bogota 

681414867

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.