Regulatory Affairs Contractor

Job not on LinkedIn

🔥 12 hours ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 14%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Abstra

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2007

💼 Consulting

📦 Logistics

📣 Marketing

💰 $2.3M Seed Round - Abstra on 2022-01

Consulting • Logistics • Marketing

Abstra is a nearshore LATAM technology services company that provides staff augmentation, dedicated teams, software outsourcing, and managed IT services to U. S. and international clients. They deliver custom software development (web and mobile), UX/UI design, QA/testing, and platform & infrastructure work (DevOps/SRE), and offer Data & AI capabilities including data engineering, ML engineering, MLOps, and data science. Abstra emphasizes time-zone alignment, bilingual LATAM talent, cost-effective nearshore delivery, and long-term partnership models to help companies scale engineering capacity and accelerate roadmaps.

📋 Description

• 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

• 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

• 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