Subiselena Paramasivam

• Supports MLR submissions and artwork production teams
• Consults with project management, medical editors, and production specialists to ensure accuracy of claims, references, and adherence to brand, style, and MLR file standards
• Utilizes annotation tools to prepare pharmaceutical material for MLR and regulatory review
• Fact-checked, proofread, edited, and annotated scientific information
• Ensured compliance with various guidelines and trained new team members
• Utilized Adobe Acrobat, Digital Interact, MS Teams, Excel, Veeva Vault Promo Mats, and PubMed.

• As a Regulatory affair for Medical devices, Maintain technical files for in vitro diagnostic products in compliance with European In Vitro Diagnostics Regulation 2017/746 (IVDR) Prepare and review RA technical file/ documentations (GSPR, TFI, SSP & DoC) for reagents, calibrators, controls and verify against relevant standards
• Review performance documents (APR, CPR, SVR) by cross-functional teams Provide regulatory review of the claims and technical files to maintain EU CE marking
• Investigate and close GAPs in documentation for technical files Communicating with cross-functional teams to address appropriate sections in technical
• Documentation
• Maintain trackers and check the progress of team with deliverables Experience with immunoassay and hematology product lines Experience with Documentum and SAP

Remediation Activities:

• Responses to EU Notified Body Preparation and Review of Technical File, GSPR, PEP, PER, CPR, APR and SVR of EU Market
• Gap Assessment of GSPR and Technical file Remediation of In-Vitro diagnostics and medical devices as per the 2017/746 & 2017/745 Regulations (IVDR & MDR)
• Prepared and submitted regulatory file applications and supporting documents to Notified body
• Constructed and peer-reviewed Technical Documentation (STeD & GSPR), Performance
• Evaluation report, analytical and clinical performance report of the medical device
• Expertise in systematic literature review for clinical writing of medical device
• Involved in protocols & reports review to assure
• Collection of appropriate data to support regulatory submission and compliance
• Trained sub-ordinates for project requirements
• Involved in Product quality assurance - Defect prevention control & Final inspection of deliverables
• Collaborate with internal functional area to ensure the production and review of the regulatory Documents within agreed upon timelines
• Work cross-functionally to ensure adherence to submission and company-driven deadlines
• Collaborate with stakeholders and participate in client calls and supporting work stream leaders
• Document knowledge on Risk management files, Safety data sheet, Stability reports, PMS report, QMS audit documents, and ISO standards
• Conducted Proofreading, editing, document formatting, review comment integration and document completion/ approval activities
• Proficiency in applicable computer and database application (i.e
• MS Word, MS Excel, MS PowerPoint, MS Visio and Adobe PDF)
• Train the sub ordinates according to the project requirements and providing knowledge transfer to the team by conducting interactive training session

Labeling Activities:

• Responsible for Redline, review, Third eye review, proofreading, revision of product labels and IFU to ensure compliance to EU regulations
• Follow up with the stakeholders to finalize the labels and IFU
• Prepared and delivered Labeling changes summary document as part of Customer notification letter.