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Urgent! Regulatory Affairs Specialist Job Opening In Colombia, Colombia – Now Hiring Kelly Science, Engineering, Technology & Telecom

Regulatory Affairs Specialist



Job description

Location
: Colombia

Contract
: 12 month with possible extension

Kelly FSP is seeking a Regulatory Affairs Specialist on behalf of our leading MedTech client

Overview:

Join a dynamic team dedicated to advancing medical technology and supporting regulatory excellence across Latin America.

As the RA Specialist, you will play a key role in ensuring our client's medical devices meet regulatory requirements, enabling safe and effective market access.

Key Responsibilities:

  • Develop, compile, and submit regulatory documentation for medical devices across Latin American markets.

  • Maintain active knowledge of regional regulatory requirements, standards, and submission processes.

  • Liaise with government agencies and local regulatory authorities in Latin America.

  • Support registration, licensing, pre/post-market surveillance, and compliance activities.

  • Provide regulatory advice to cross-functional teams, including R&D, clinical, and quality.

  • Monitor changes in regional regulations and update internal teams and documentation accordingly.

  • Participate in audits, inspections, and ensure continued compliance of product portfolios.

Qualifications & Skills:

  • Bachelor's degree in life sciences, engineering, or related field.

  • Minimum of 3 years of proven experience in Regulatory Affairs within the medical device sector.

  • Hands-on experience with Latin American regulatory frameworks.

  • Strong understanding of medical device submissions, approvals, and compliance processes.

  • Excellent communication skills in English; Spanish fluency highly advantageous.

  • Proactive, detail-oriented, and collaborative team player.

Apply today to contribute to meaningful healthcare solutions and support regulatory excellence with a premier MedTech client


Required Skill Profession

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    Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


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