Regulatory Affairs Contractor

The Regulatory Affairs Contractor will provide regulatory support for medical device portfolio and business integration activities. The role will work closely with Regulatory Affairs and cross-functional partners to support global regulatory planning, product registrations, lifecycle management, and execution of integration-related regulatory activities.

The ideal candidate will have hands-on medical device Regulatory Affairs experience and be comfortable independently managing multiple global regulatory deliverables in a fast-paced, cross-functional environment.

Location:Remote - Colombia Only

About the Company:

Abstra is a fast-growing, Nearshore Tech Talent services company, providing top Latin American tech talent to U.S. companies and beyond. Founded by U.S.-bred engineers with over 15 years of experience, Abstra specializes in sourcing skilled professionals across a wide range of technologies to meet our clients’ needs, driving innovation and efficiency.

Key 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, labelling, supplier, site, and quality system changes.

- Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions, as applicable.

- 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 escalate regulatory risks, dependencies, and potential impacts to business or integration timelines.

Required Qualifications:

- 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.

Preferred Experience:
- 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.

What We Offer:

- 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.

Pre-Employment Verification:
As part of our standard onboarding process, candidates who successfully complete the interview process and accept an employment offer will b