Top 6 Technical writers Jobs in Puerto Rico

Dossier Excellence Specialist (Regulatory Affairs - Medical Devices)
ECONS —San Juan, PR
- $28 - $30 an hour
- Contract
- Microsoft Excel
- Microsoft Outlook
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Technical Writer & Systems Documenter
Unicity USA Inc —Guaynabo, PR
- $60,000 - $90,000 a year
- Full-time
- Mid-level
- Paid parental leave
- Paid holidays
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Scientific Writer
Ladgov Corporation —San Juan, PR
- Part-time
- 5 years
- Master's degree
- Senior level
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Specification Preparation Writer
Kundlas Consulting Group LLC —San Juan, PR
- Mid-level
- Analysis skills
- Quality control
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Dossier Excellence Specialist (Regulatory Affairs - Medical Devices)

ECONS
San Juan, PR

Quick Apply

Job Details

Contract
$28 - $30 an hour
3 days ago

Qualifications

Teamwork
Microsoft Excel
Microsoft Outlook
Technical documentation
English
Attention to detail
Organizational skills
Microsoft Teams
Technical writing experience within technology
Achieving project delivery timelines
FDA regulations

Full Job Description

Location: Puerto Rico (Remote)
Employment Type: Full-Time
Industry: Medical Devices / Life Sciences / Regulatory Affairs

About the Opportunity

We are seeking a detail-oriented Dossier Excellence Specialist to support regulatory affairs operations for medical device products in global markets. This position plays a critical role in the preparation, organization, maintenance, and submission readiness of regulatory dossiers while ensuring compliance with applicable regulatory requirements, company procedures, and quality standards.

The ideal candidate is highly organized, skilled in technical documentation management, and capable of working in a fast-paced regulatory environment supporting international submissions.

Key Responsibilities

Gather and compile technical and regulatory documentation required for dossier preparation.
Follow up with cross-functional teams to obtain pending documents and supporting information.
Perform technical writing activities for specific dossier sections and regulatory documentation.
Prepare regulatory dossier packages following established procedures, templates, and quality requirements.
Upload, organize, and maintain documentation in electronic document management systems.
Ensure documentation accuracy, completeness, traceability, and version control.
Support local and global regulatory submissions through effective document management practices.
Participate in regulatory and quality training programs and remain current with evolving regulations and requirements.
Maintain accurate information within MDRIM and other applicable electronic systems.
Collaborate with Regulatory Affairs, Quality, Engineering, Manufacturing, and Product Lifecycle Management teams.
Meet established timelines and performance objectives while maintaining high-quality standards.
Identify documentation gaps and proactively work toward resolution.

Responsibilities include dossier preparation, technical writing, document gathering, document tracking, submission support, electronic records management, training participation, and maintenance of regulatory systems.

Required Qualifications

Bachelor's Degree in Science, Engineering, Life Sciences, Regulatory Affairs, Quality, Technical Writing, or a related discipline.
Minimum 2 years of experience in Regulatory Affairs, Quality Systems, Documentation Control, Medical Devices, Pharmaceuticals, Biotechnology, or a regulated industry.
Experience working with technical documentation and controlled documents.
Strong document management and organizational skills.
Excellent written and verbal communication skills in English.
Proficiency with Microsoft Office Suite (Word, Excel, Outlook, Teams).
Ability to manage multiple projects and deadlines simultaneously.
Strong attention to detail and commitment to quality.

Preferred Qualifications

Experience supporting Medical Device regulatory submissions.
Knowledge of international regulatory requirements.
Experience with Product Lifecycle Management (PLM) systems, document repositories, or regulatory information management systems.
Familiarity with MDRIM, Agile, Windchill, SAP, TrackWise, Documentum, or similar platforms.
Experience in a Johnson & Johnson, FDA-regulated, ISO 13485, or comparable environment.

Key Competencies

Regulatory Documentation Management
Technical Writing
Data Accuracy & Compliance
Attention to Detail
Problem Solving
Time Management
Cross-Functional Collaboration
Continuous Improvement Mindset
Customer Focus

What Success Looks Like

Dossiers are completed accurately and on schedule.
Regulatory documentation is complete, traceable, and submission-ready.
Electronic systems remain current and accurate.
Stakeholders receive timely support for regulatory submission activities.
Documentation quality meets established regulatory and business requirements.

Pay: $28.00 - $30.00 per hour

Work Location: In person

Quick Apply

Refine Your Search

technical writers jobs in puerto rico

Dossier Excellence Specialist (Regulatory Affairs - Medical Devices)

Technical Writer & Systems Documenter

Scientific Writer

Specification Preparation Writer

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