Smridula Hariharan Email & Phone Number

India

India

Delivery manager for medical devices and invitro diagnostics team

Hyderabad, Telangana, India

India

Provide guidance, insights and training for the medical writing team for medical devices and in vitro diagnostics, equipped to handle several different types of reports including sscp, PMSR, psur, cer, svr, per, pep, identify gaps or improvements to process to facilitate better quality documents in shorter timeframe, ensure increased efficiency and productivity of the team, maintain client relations, provide apt solutions to client questions regarding regulatory compliance to mdr /ivdr

Hyderabad Area, India

Team lead for regulatory writing - CER, SVR, PERs, SSCP, PMCF PLANS, PSURS, PMSRs

Developing templates for regulatory documents required as per EU MDR, WRITING AND REVIEW of CERs, training the team on different aspects of the medical device regulations and regulatory Documents.

Hyderabad Area, India

Writing and review of CERs to ensure compliance with MEDDEV REV 4 AND MDR

Raheja Mindspace Hyderabad

writing safety narratives, reporting SUSARS, labeling, coding events, conducting trainings

Hyderabad

Writing and review of CERs, safety narratives, submission of meddev compliant reports, coding of safety events

Hyderabad

Masters Of Pharmacy, Quality Assurance

Bachelor Of Pharmacy, Pharmacy, Pharmaceutical Sciences, And Administration

Icse Tenth