Regulatory Affairs Contractor

Abstra

. Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems .

Posted 9/15/2026full-timeRemote • ColombiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global Regulatory Affairs, including the development and maintenance of Global Regulatory Plans, and supports compliance with FDA and EU MDR requirements. Capable of managing multiple regulatory deliverables while collaborating with cross-functional teams to ensure market access and integration of medical device products.

Highest-signal resume keywords

Global Regulatory PlanningFDA Medical Device RequirementsEU MDR ComplianceRegulatory Change AssessmentsMedical Device Lifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationGlobal Product RegistrationsRegulatory Impact AssessmentRegulatory TrackersClass II/III Medical DevicesRegulatory AffairsIntegration ActivitiesQuality System TransitionsMarket-Specific Regulatory RequirementsTechnical Documentation Updates

Soft Skills

Organizational SkillsWritten CommunicationProblem-Solving SkillsCollaboration

Industry Keywords

Medical DeviceRegulatory AffairsLife SciencesEngineeringGlobal Regulatory PlansMarket AccessComplianceCross-Functional CollaborationRegulatory RisksIntegration Timelines

About the role

Key responsibilities & impact

Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems
Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation
Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements
Assess regulatory impact of product, manufacturing, labelling, supplier, site, and quality system changes
Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions
Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access
Support EU MDR and other global regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications
Review existing regulatory documentation, identify gaps, and coordinate actions required to support integration and ongoing compliance
Maintain regulatory trackers, plans, and deliverables and ensure activities are completed according to established timelines
Partner with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration activities
Identify and escalate regulatory risks, dependencies, and potential impacts to business or integration timelines

Requirements

What you’ll need

Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline
3–5+ years of medical device Regulatory Affairs experience preferred
Experience with global medical device registrations and lifecycle management
Working knowledge of FDA medical device requirements and EU MDR
Experience with additional international markets preferred
Experience with regulatory change assessments, global regulatory planning, and/or business or product integration activities preferred
Ability to independently manage multiple regulatory deliverables and collaborate effectively across global teams
Strong organizational, written communication, and problem-solving skills
Experience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and integration or transition of established medical device portfolios is highly desirable
Successful completion of employment verification and background checks
Employment verification confirming job titles and dates of employment with two previous employers

Benefits

Comp & perks

Competitive compensation paid in USD
20 days of paid time off (PTO) per year
Opportunities for professional growth and career development
Company-provided equipment
A collaborative, inclusive, and multicultural work environment
The opportunity to contribute to meaningful projects alongside a talented and supportive team