PEDRO JUAN "PJ" PARDO
Gainesville,USA
Summary
Multilingual regulatory professional specializing in global medical device compliance and clinical documentation. Expertise in clinical evaluation, literature research, and regulatory submissions, with a focus on cross-functional collaboration and risk-benefit analysis. Proven ability to drive product approvals and ensure regulatory adherence while maintaining clarity and scientific integrity.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Senior Medical Writer
Reliant Life Sciences
Menlo Park, USA
05.2021 - 01.2026
- Managed the development, editing, and completion of clinical and regulatory documentation that helped the business obtain CE Mark and regulatory approval for a Class IIa glaucoma medical device.
- Developed and maintained CERs, CEPs, PMCF Plans/Reports, and Periodic Safety Update Reports (PSURs) ensuring compliance with evolving regulatory standards.
- Applied regulatory strategies to ensure seamless compliance with evolving European Union (EU) and United Kingdom (UK) medical device regulations.
- Collaborated cross-functionally to produce accurate, timely, and comprehensive documentation for regulatory submission, facilitating regulatory approval.
- Oversaw migration from Medical Device Directive (MDD) to Medical Device Regulation (MDR), validating deliverables for alignment with clinical evidence expectations and regulatory compliance standards.
- Conducted literature and State-of-the-Art (SOTA) reviews to synthesize evidence for regulatory submissions, enhancing submission quality and facilitating successful approvals.
- Performed comprehensive literature reviews to gather relevant data for regulatory submissions. to support evidence-based writing initiatives.
- Guided junior writers to improve their skills and understanding of industry standards.
- Collaborated with teams to align messaging across departments.
Regulatory Medical Writer
ALKU / Hologic, Inc.
Andover, Massachusetts
02.2021 - 01.2022
- Ensured clinical documentation for skeletal and breast health product lines met regulatory expectations and scientific standards, facilitating compliance for clinical affairs team.
- Reviewed clinical files for accuracy and consistency, ensuring readiness for regulatory inspections.
- Edited and reviewed content for clarity, consistency, and adherence to guidelines.
- Integrated clinical findings into finalized documentation by coordinating closely with cross-functional teams to enhance clarity and accuracy.
- Developed and refreshed post-market follow-up strategies and reports to enhance compliance and strengthen risk monitoring.
Regulatory Medical Writer
Eliassen Group, LLC – contracted to Mentor World's
Reading, Massachusetts
06.2021 - 12.2021
- Created clear and concise medical documents for regulatory submissions, improving clarity and ensuring compliance.
- Developed regulatory strategies and processes, enabling timely global commercialization of products while adhering to regulations and standards.
- Prepared international documentation, facilitating efficient product registration across multiple markets.
- Assessed modifications to device safety and effectiveness for regulatory submissions
- Reviewing and approving new product development and product modification documentation
- Writing, reviewing and revising company SOPs, CEPs, CERs, and other documents for MDR compliance
- Prepared and submitted changes to the manufacturing procedure to the FDA with a 30-day notice.
- Submitted changes in manufacturing procedures or methods to the FDA with a 30-day notice.
Clinical Evaluation Scientist
Bannick, LLC
Minneapolis, Minnesota
01.2020 - 12.2021
- Delivered strategic clinical and regulatory support for medical device clients, producing evidence-based documentation that ensured product safety and regulatory compliance, contributing to timely market access.
- Coordinated preparation and submission of regulatory filings, including pre-submission packages, investigational device exemptions (IDEs), 510(k) submissions, and technical documentation, streamlining approval processes and enhancing client confidence.
- Advised on clinical strategy and regulatory pathways, guiding clients through complex compliance requirements.
- Developed and finalized clinical evaluation reports (CERs), clinical evaluation plans (CEPs), and post-market clinical follow-up (PMCF) deliverables, facilitating licensing and certification for multiple device portfolios.
- Evaluated clinical data, study findings, and field performance metrics to support risk assessments and shape regulatory recommendations.
Medical Device RA/QA EU-MDR Management Consultant
Oriel STAT A MATRIX
Edison, New Jersey
01.2020 - 06.2020
- Consulted on client project in cep, cer, and lsp, conducted literature searches, and generated risk management reports, improving compliance with EU-MDR standards.
- Analyzed client operations to identify process improvement opportunities, resulting in streamlined workflows and enhanced regulatory readiness.
- Led workshops to facilitate stakeholder engagement and collaboration, fostering alignment on regulatory objectives and improving project outcomes.
- Developed strategic recommendations that drove organizational growth and enhanced operational efficiency.
Director, Regulatory and Clinical Affairs
Lifeline Scientific, Inc. / Organ Recovery Systems, Inc.
Itasca, USA
01.2005 - 12.2019
- Directed global regulatory and clinical operations for premier medical device manufacturer, achieving compliance in product safety and aligning clinical strategy with regulatory standards.
- Managed worldwide regulatory submissions for FDA 510(k) applications and EU-MDR registrations, ensuring timely compliance with regional regulations.
- Led clinical trials in US and China, maintaining study integrity and regulatory compliance for device evaluation.
- Oversaw cross-functional teams in regulatory submissions, quality assurance, and post-market activities to align with international standards.
- Directed quality systems functions, implementing corrective/preventive actions (CAPA), product complaint vigilance reporting, and audits to uphold product quality standards.
- Authored Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), risk-benefit analyses, and post-market surveillance documentation.
- Resolved FDA warning letter, executing multiple product recall requests to uphold compliance with regulatory standards and enhance product safety.
- Resolved FDA warning letter, executing multiple product recall requests to ensure adherence to regulatory requirements and safeguard product safety.
Education
Doctor of Philosophy - Organization and Management
Capella University
Minneapolis, MN01-2011
Master of Quality Assurance - Manufacturing Quality Assurance
California State University–Dominguez Hills
Dominguez Hills, CA12-1999
Master of Science - Healthcare Policy and Administration, General Healthcare Administration, Single Payer System
Mercer University – Stetson School of Business And Economics
Atlanta, GA06-1993
Bachelor of Science - Microbiology, Minor in Chemistry
University of Florida, College of Liberal Arts And Sciences
Gainesville, FL12-1984
Skills
- Regulatory writing
- Clinical planning
- Clinical data interpretation
- Risk-benefit analysis
- Statistical protocols
- Quality assurance
- Scientific communication
- Review automation
- Project management
- Global collaboration
- Cross-functional leadership
- Therapeutic area knowledge
- Statistical software
- Embase proficiency
- PubMed experience
- DistillerSR tools
- Device regulations
- Microsoft Office proficiency
- Reference management
Certification
- State of Florida Clinical Laboratory Technologist, Not Active
- American Society of Clinical Pathologists – Medical Technologist, Active
- BSI ISO 13485:2016 Lead Quality Auditor (TPECS), 8499762-146772
Core Proficiencies
- Clinical Evaluation Plans/Reports
- Literature Reviews
- Risk-Benefit Analysis
- Clinical Data Interpretation
- Statistical Analysis
- Cross-Functional Leadership
- Project Management
- Scientific Communication
- Remote & Global Collaboration
- Multi-Document Oversight
Languages
English
Native/ Bilingual
Spanish
Native/ Bilingual
Italian
Professional
French
Professional
Portuguese
Limited
Timeline
Regulatory Medical Writer
Eliassen Group, LLC – contracted to Mentor World's
06.2021 - 12.2021
Senior Medical Writer
Reliant Life Sciences
05.2021 - 01.2026
Regulatory Medical Writer
ALKU / Hologic, Inc.
02.2021 - 01.2022
Medical Device RA/QA EU-MDR Management Consultant
Oriel STAT A MATRIX
01.2020 - 06.2020
Clinical Evaluation Scientist
Bannick, LLC
01.2020 - 12.2021
Director, Regulatory and Clinical Affairs
Lifeline Scientific, Inc. / Organ Recovery Systems, Inc.
01.2005 - 12.2019
Doctor of Philosophy - Organization and Management
Capella University
Master of Quality Assurance - Manufacturing Quality Assurance
California State University–Dominguez Hills
Master of Science - Healthcare Policy and Administration, General Healthcare Administration, Single Payer System
Mercer University – Stetson School of Business And Economics
Bachelor of Science - Microbiology, Minor in Chemistry
University of Florida, College of Liberal Arts And Sciences