Regulatory Affairs Contractor
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked 2h ago — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 18d ago
The date the source published, not the day we noticed it (2026-09-15). Last seen at its source 2h ago.
Is it remote?
Marked remote on the employer's board
Their board carries a remote setting on this posting — a field they filled in, not wording we read. The location field names somewhere specific, which is usually where the team or the entity sits.
Who may apply?
Colombia
No source stated where this role may be worked. This is read from the ad's own words.
What the ad says
…Location : Remote - Colombia Only About the…
Pay not stated
Similar roles pay $109.0k–194.2k/yr
Middle 50% of 472 listings that do state pay — Legal & Compliance · all levels · Americas · USD/year. This employer has published no salary; this is what comparable listings we hold disclose, never converted between currencies or periods. How this is calculated.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
-
bamboohr employer's own board first seen 2h ago · last seen 2h ago
- location not stated
The listing
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 be required to complete an employment verification check, and background check. This process will confirm job titles and dates of employment with two previous employers and is a standard requirement for all new employees joining the company.