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
