Padmini Suravaram

About Padmini Suravaram

Responsible for Cybersecurity & Product Security Strategy, Digital Health RA Strategy, Labeling Strategy, 510k submissions, Laser & Radiation Reports, RTTE reports, EU MDD & MDR Technical file, STED compilations, Letter to file compilations for product & process changes, Manufacturing Moves, Health Canada New Product and Amendment Submissions, Notifications to Notified Bodies, Clinical Evaluation Reports, Developing content for IFUs & Labels • Responsible for Radio component registration, Establishment Registrations, Product Listings and GUDID • Proven roles as Country Expert & Product Expert • Sound Understanding on US, EU, Canada, Australia • Responsible for New Product Submissions & Renewals worldwide • Experience with MDSAP & several other audits • Responsible for Product Release Authorizations, Submission Event Records in the Regulatory Database, Review and approval of the Change Orders & Change Requests • Responsible for reviewing service calls & reporting complaints • Responsible for ship reviews • Responsible for the change notification process to gather international regulatory impact and timely completion Of International Regulatory Activities • Responsible for leading the Global Labeling System as Regulatory Core Team Member and Analyzing the Country Specific Labeling & IFU requirements as a part of the Global Labeling System Implementation project • Responsible for active interaction with cross-functional teams to adhere to the timelines of the submissions & Supplementary requests. • Responsible for analysis of the changes and assessment of their possible regulatory impact on geographies. • Solid interaction with the In-Country Affiliates & Distributors to communicate product submission statuses, strategy & review deficiencies. • Solid Interaction with Cross-Functional Teams. • Responsible for writing the software description documents specific to China as per the guidance.

Experience

1. Principal Regulatory Affairs Specialist

   Stryker

   Oct 2023 — Present

Education

• Wageningen University, The

  Masters

• Northeastern University

  Masters

• Osmania University

  Bachelors