Mansi Shah

• Regulatory Submissions: Prepare and submit regulatory documents, including Clinical Evaluation Reports (CERs), to regulatory authorities.
• Data analysis: Collaborate with clinical teams to gather and interpret clinical data.
• Compliance: Ensure all documents comply with regulatory standards and guidelines.
• Literature Reviews: Conduct and evaluate literature searches to support clinical evaluations.
• Project management: Manage timelines and ensure the timely completion of regulatory documents.
• Communication: Clearly communicate complex clinical and technical information to various stakeholders.
• Quality Control: Review and edit documents for clarity, accuracy, and consistency.

Quality Assurance (QA)

• QMS Oversight: Maintain and implement Quality Management System.
• Internal Audits: Conduct regular audits for compliance.
• Supplier Management: Ensure Management: Ensure suppliers meet quality standards
• CAPA: Manage corrective and preventive actions.
• Product testing: Oversee product testing and validation.
• Training: Train staff on quality procedures

Regulatory Affairs (RA)

• Regulatory Submissions: Prepare and submit documents to regulatory bodies.
• Compliance monitoring: Ensure products comply with regulations.
• Product registration: Manage product registrations.
• Labeling review: Ensure labels and artworks meet regulatory standards.
• Audits and Inspections: Prepare for regulatory audits.

Combined Responsibilities

• Risk Management: Identify and mitigate risks.
• Documentation: Maintain records of QA and RA activities.
• Collaboration: Work with other departments to ensure compliance

• To prepare Report Description on the basis of secondary research of market trends, financial statistics, growth strategies
• To analyze, monitor and report market trends and forecasts
• Derive strategic insights and inputs on market situation.