Regulatory Affairs Project Leader in Pleasanton, CA at Volt

Date Posted: 11/22/2020

Job Snapshot

Job Description

Regulatory Affairs Project Leader for a large Medical Device company located in Pleasanton CA

Ideal candidate will Provide regulatory direction and strategy to the products for the EU MDR Program

Responsibilities

  • Strategize and provide clarity on various matters related to the EU MDR and overall impact to business
  • Strive to complete important Regulatory deliverables for product portfolio including Classification Assessment, Technical Documentation
  • Navigate and provide regulatory input to the develop approaches and methodologies based on the new EU MDR requirement
  • Be a regulatory Liaison to ensure Annex 1 General Safety and Performance Requirements for EU MDR are met and identified gaps and addressed through a rational and data driven approach
  • Ensures inputs to Risk Management Files updates are adequately provided for compliance to ISO 14971:2019 standard

Qualifications

  • Bachelor's degree required, Master's degree preferred
  • Minimum of 3 years’ experience
  • Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)
  • Project management experience
  • Working knowledge of the EU Medical Device Regulation
  • Cross functional understanding of Design Control, Risk Management, Clinical Affairs as required to support RA submissions

Volt is an equal opportunity employer