Profile Details

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USD 39 /hr

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Hire Ninja P.

Canada

USD 39 /hr

Regulatory Affairs Professional (Medical Device Consultant)

Profile Summary

An aspirational mind whose main interest is to pursue a career and advance in Regulatory Affairs and Quality Assurance, become part of an esteemed organization, where I can use my strong knowledge, skills, and experience to contribute to Design Dossiers, MDSAP, Audit, Compliance, CAPA, Deviation reports, ISO 13485, ICH/GCP guidelines, Clinical study monitoring, SOP writing, able to prepare and file medical device applications to USFDA health and Canada. Able to do project planning for the growth of the organization.

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ☆ Medical Devices
• ☆ ISO 13485
• ☆ Regulatory Affairs
• ☆ Medical Writing

Services

• Writing
• Product Development

Writing Technical Writing

Product Development Product Evaluation

Work Experience

RA/QA Specialist

Diros Technology

June 2023 - Present

Regulatory affairs consultant

Q and R consulting

March 2022 - Present

Education

Regulatory Affairs Medical Device

Northeastern University

September 2021 - June 2022

Certifications

• Intermediate Medical Writing: Medical Devices

  RAPS

  March 2022 - Present