Dhara Joshi

About Dhara Joshi

Passionate about navigating the complex regulatory landscape to drive compliance excellence and ensure business success. I bring over 4 years of experience in regulatory affairs, specializing in the medical device and IVD industry. My expertise lies in crafting strategic regulatory solutions, fostering cross-functional collaboration, and championing a culture of compliance. Professional Highlights- Regulatory Strategy: Developed and executed robust regulatory strategies, ensuring product compliance and market access while minimizing risks- Cross-functional Collaboration: Collaborated seamlessly with R&D, Quality Assurance, Legal, and other departments to integrate compliance measures into product development life cycles- Regulatory Submissions: Expertise in preparing and submitting regulatory documentation, ensuring adherence to domestic and global standards and regulations for Class II and Class - Medical Devices, SaMDs, SiMDs, CDx, and IVDs- Audit and Inspection Management: Successfully managed regulatory audits and inspections, resulting in commendations for compliance and adherence to regulatory standards. Skills- Comprehensive knowledge of the US FDA, EU, and Rest-of-the-World (ROW) regulatory guidelines and framework- Hands-on experience preparing and compiling PMA, 510(k), IDE, and ANDA submissions- Well-versed in preparing and managing international submissions for the EU (CE-Marking), UK (UKCA Marking), Australia, LATAM, China, etc- In-depth knowledge of domestic and international regulatory frameworks for drug/device approvals and registrations – US, EU, ASPAC, and LATAM- Quality System Regulations: cGMP, GLP, 21 CFR Part 11, 21 CFR 820 QSR, CAPA, CMC, ISO 13485, ISO 14971, SOP compilation- Clinical Trails: Clinical documentation, IRB submission, Clinical Study Protocol, GRAS documentation, Study manuals, Informed Consent Form.🤝 Let\'s Connect:I am always open to connecting with professionals who share a passion for regulatory excellence, compliance, and industry advancement. Let\'s connect to explore potential collaborations, share insights, and build a network that fosters growth and success.

Experience

1. Sr Regulatory Affairs Specialist

   Boston Scientific

   Jul 2023 — Present · Houston, TX, US

Education

• Dr. Bhanuben Nanavati College of Pharmacy , Mumbai University.

  Bachelor's in Pharmacy

  2013 — 2017

• Northeastern University

  Master's in Pharmacy Administration , Pharmacy Policy and Regulatory Affairs