Shraddha More Email & Phone Number

Bloomfield, NJ, US

Kalamazoo, MI, US

Kalamazoo, MI, US

- Developing regulatory talent in orthopedic regulatory framework- Leading divisional and global regulatory process integration strategies- Reviewing regulatory documentation for patient specific devices, internal regulatory assessments for standards device changes, counseling newer staff on developing MDD and MDR submissions- Led three EUMDR audits for.

Kalamazoo, MI, US

- Authored several regulatory documentation to support global distribution of patient specific devices in oncology patients- Authored multiple FDA submissions for compassionate use devices and achieved timely approvals - Collaborated with cross functional teams in procedural updates and streamlining - Executed procedural updates with changing regulatory.

Paramus, NJ, US

- Developed and executed regulatory strategies for global launch of a dental product line in 20 countries including EU, Canada, Asia, Middle East and Russia markets. - Authored EU Change Notifications and Renewals. Interacted with Notified body directly.- Developed Summary Technical Documentation (STED)s and international dossiers for markets in Russia.

Lexington, Massachusetts, US

- Mentored a RA specialist in developing expertise on USFDA regulatory submissions for endoscopy products.- Authored 5 premarket notifications (510k) for Class II endoscopy devices, including software components. Interacted directly with the regulatory agencies such as USFDA and Health Canada.- Provided guidance to Product Development and Marketing teams.

Lexington, Massachusetts, US

• Developed 7 premarket notifications (510k) for Class II endoscopy devices. Authored and submitted 4 of them.
• Authored and submitted 5 Health Canada applications for Class II endoscopy devices.
• Authored regulatory assessments for post-market modifications to Class II endoscopy medical devices.
• Created Standard Operating Procedures for regulatory processes.
• Participated in a FDA inspection and assisted in developing and executing response to Form 483.

Reston, VA, US

Reston, VA, US

• Developed and documented business requirements with FDA Mercado end users and technical teams for analytical reports, based on agency's regulatory processes such as 21st Century Review process for NDAs and BLAs, ANDAs.
• Acted as a Subject Matter Expert on Adverse event reporting systems and overall agency understanding.
• Created and executed test scripts to determine the compliance of the reports with agency's requirements.
• Developed and updated CMMi level-3 documentation on tools such a SharePoint, FDA's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), Adverse Event Reporting system (FAERS).
• Developed and updated business and project plans in tools such Microsoft Project Pro and Microsoft Visio.

Bridgewater, NJ, US

• Assisted in domestic and global registrations and renewals Class II medical devices in countries such as China, Korea and New Zealand.
• Assisted in developing Health Canada license files and supporting documentation.
• Assisted in developing recall filing system for Class III medical devices.
• Worked with document development and archival tools such as adobe acrobat editor, Documentum, SharePoint, Catsweb.
• Participated in LGA Notified Body audit as a backroom supporter.

• Developed a comprehensive Quality Management System compliant with 21CFR 820 and ISO 13485 standards, for facilities developing Class II and Class III medical devices.
• Authored document templates and components for Design History File, Device Master Record, Device History Record
• Established understanding and implemented fundamentals of Design Controls, Standard Operating Procedures, Assembly development documentation with R&D teams.
• Authored and implemented detailed Risk and Biocompatibility assessment plans and documentation compliant to ISO 14971 and ISO 10993, and IEC 60601 standards.
• Developed Regulatory routes for HUD devices, worked on developing sections of HUD and HDE applications.
• Actively participated in developing a NIH Small Business grant for developing a clinical and reimbursement strategy for a class II device.

• Assisted in drug patent filing process.
• Assisted in ANDA filing and CTD interface.
• Assisted in preparation and submission of annual reports.
• Maintained drug production specification in Drug Master Files (DMF) and production information databases.
• Maintained regulatory requirement matrices.
• Carried out in depth research on US-FDA regulations and ISO standards.

Masters, Regulatory Science

Masters, Pharmaceutical Biotechnology

Bachelors Of Pharmacy, Pharmaceutical Sciences