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Assoc Regulatory Affairs Spec

hace 3 semanas

Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Associate Regulatory Affairs Specialist plays a key role in supporting global regulatory activities by managing documentation, coordinating submissions, and ensuring compliance with evolving regulations. This position is ideal for someone with foundational experience in regulatory affairs, strong organizational skills, and a collaborative mindset.

As part of a multicultural global team, the specialist will contribute to strategic reviews, support cross-functional projects, and maintain regulatory tracking tools. The role is remote, with twice-monthly in-office presence required for team activities. Candidates must reside in Colombia, preferably Bogotá, though other cities will be considered.

Responsibilities may include the following and other duties may be assigned:

  • Provide timely status updates on assigned projects and regulatory activities
  • Prepare and follow up on insight applications, events, and tasks
  • Complete local registration applications and support document distribution (CFGs, FSCs, ISOs)
  • Assist with translations and legal documentation for assigned clusters or delegated units
  • Collaborate with RA Manager or Sr Supervisor on monographs, technical charts, and submission packages
  • Coordinate with Business Partners and Operating Units to ensure submission planning
  • Respond to government inquiries and support RACs requiring prior approval
  • Notify stakeholders of approvals across international, regional, and local teams
  • Validate and verify data for publication in regulatory databases
  • Participate in internal training on local regulations and SSC-led initiatives
  • Support statistical reporting, budget tasks, and regulatory operations (e.g., blocked orders, batch releases)
  • Contribute to audits, importations, tenders, and inventory deployment as needed
  • Maintain tracking tools (Excel, Smartsheet) for regulatory process advancement
  • Actively engage in strategic reviews and SSC projects
  • Provide backup support to fellow Regulatory Affairs Specialists

Required Knowledge and Experience:

  • Bachelor's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or related field
  • Advanced proficiency in Spanish and English (reading, writing, speaking)
  • Strong verbal and written communication skills
  • Ability to work in a matrix-structured organization
  • Solid understanding of regulatory sources and global submission types
  • Proficiency in Microsoft Office Suite and database management
  • Strong organizational, analytical, and time management skills
  • Ability to follow detailed instructions and produce accurate, high-quality work

Preferred Qualifications:

  • Experience in medical devices or pharmaceutical industry
  • Strategic thinking and problem-solving abilities
  • Familiarity with document interpretation, workflow systems, and regulatory tracking tools
  • Team-oriented mindset with a proactive approach to collaboration
  • Comfort with remote work and global communication platforms

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here