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Remote Fda Jobs in Puerto Rico (NOW HIRING)

Case Review Representative

Guaynabo, PR · On-site +1

$13 - $15/hr

Remote/hybrid work experience preferred * A minimum of 2 years of healthcare related administrative ... Since 2018, the FDA approved 121 new cancer applications including 49 novel cancer drug entities.

Remote Fda information

What are the typical daily responsibilities of a Remote FDA Compliance Specialist?

A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.

What is a Remote FDA job?

A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.

What are the key skills and qualifications needed to thrive in the Remote Fda position, and why are they important?

To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.

What are the most commonly searched types of Fda jobs in Puerto Rico? The most popular types of Fda jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Remote Fda jobs? Cities in Puerto Rico with the most Remote Fda job openings:
Infographic showing various Remote Fda job openings in Puerto Rico as of July 2026, with employment types broken down into 77% Full Time, and 23% Part Time. Highlights an 100% Remote job distribution.
Senior Engineering/ IT Program Manager

Senior Engineering/ IT Program Manager

Three Point Solutions, Inc.

Ponce, PR • On-site, Remote

$113K - $113K/yr

Full-time

This job post has expired today. Applications are no longer accepted.


Job description

Job Title: Senior Engineering/ IT Program Manager
Client: Medical Device Manufacturing Company
Duration: 12 Months
Location: 100% Remote (Travel to Ponce, Puerto Rico as needed)

Role Overview
  • Lead large cross-functional engineering programs
  • Support manufacturing, digital transformation, and regulated systems
  • Work across Engineering, Manufacturing, Quality, Regulatory, and IT

Program Leadership
  • Manage enterprise engineering programs
  • Build roadmaps, milestones, and resource plans
  • Deliver within scope, time, and budget

Manufacturing & Systems
  • Lead MES and automation initiatives
  • Oversee CSV, IQ/OQ/PQ validation
  • Ensure FDA, ISO 13485, GxP, 21 CFR Part 11 compliance
  • Support digital manufacturing transformation

Risk & Compliance
  • Maintain RAID logs
  • Drive risk mitigation
  • Ensure audit readiness

Cross-Functional
  • Lead global engineering teams
  • Manage stakeholders
  • Escalation point for risks and constraints

Governance & Reporting
  • Executive status reporting
  • Maintain program plans and documentation
  • Track budget and financials

Required Qualifications
  • Bachelor's in Engineering / CS
  • 10+ years in regulated industries (Med Device / Pharma)
  • Strong in MES, CSV, automation
  • Regulatory knowledge (FDA, GxP, Part 11)
  • Large team leadership (50+ preferred)
  • Agile & Waterfall experience
  • Enterprise-scale program delivery
  • Willing to travel to Puerto Rico

Preferred
  • PMP or Scrum Master
  • Global manufacturing deployments
  • ERP / SAP / LIMS exposure
  • Site expansion or transfer programs
  • Digital transformation or PMO background

Key Skills
  • Executive communication
  • Stakeholder management
  • Strategic roadmaps
  • Regulatory mindset
  • Budget control
  • Change management
  • Influence without authority