Remote Medical Device Regulatory Affairs Contractor

Abstra; Colombia; Remote; COP 291,300,000 - 420,766,000; Part time

Benefits offered by this job

Competitive compensation (USD)

PTO 20 days

Career development

Company equipment

Inclusive work environment

Meaningful projects

Job summary

Abstra is seeking a Regulatory Affairs Contractor to support medical device regulatory activities for an integrated portfolio. The role is remote with Colombia-only scope and collaborates with cross-functional teams to manage GRPs, registrations, and lifecycle tasks.

The ideal candidate has hands-on medical device regulatory experience, can manage multiple deliverables globally, and navigate FDA/EU MDR requirements. The position offers USD compensation and growth opportunities.

Qualifications

• Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline.
• 3–5+ years of medical device Regulatory Affairs experience.
• Experience with global medical device registrations and lifecycle management.
• Working knowledge of FDA medical device requirements and EU MDR; international markets preferred.

Responsibilities

• 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, labeling, supplier, site, and quality system changes.
• 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, as applicable.
• 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 elevate regulatory risks, dependencies, and potential impacts to business or integration timelines.

Education

Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline

Job description

Abstra is seeking a Regulatory Affairs Contractor to support medical device regulatory activities for an integrated portfolio. The role is remote with Colombia-only scope and collaborates with cross-functional teams to manage GRPs, registrations, and lifecycle tasks.

The ideal candidate has hands-on medical device regulatory experience, can manage multiple deliverables globally, and navigate FDA/EU MDR requirements. The position offers USD compensation and growth opportunities.