Sr. Regulatory Affairs Specialist

Austin, TX 78746

Employment Type: Direct Job Category: Medical Management Job Number: 46017

Sr. Regulatory Affairs Specialist

 

The Sr. Regulatory Affairs Specialist is responsible for the creation, preparation and achievement of regulatory submissions and approvals to introduce products in the US, and may assist with submissions to international markets. The person in this role recommends and implements regulatory strategies and company initiatives and ensures company compliance to applicable regulatory requirements.

 

SPECIFIC JOB DUTIES:

 

  • Plan, coordinate, and prepare regulatory submissions of various types, such as: including US FDA 510(k) premarket notifications, PMA supplements and notices, PMA Annual Reports, EU technical documentation, international dossiers and internal Letters to File.
  • Develop detailed strategies and perform activities necessary to secure domestic regulatory clearance/approval/registration.
  • Communicate submission requirements to product development and process improvement teams.
  • Review and approve design, product and manufacturing changes,
  • Review and approve labeling, web page content and promotional materials for compliance with submissions and applicable regulations: analyze and recommend appropriate changes.
  • Serve as internal consultant to project teams, providing Regulatory Affairs feedback and guidance on new product development, design changes, as well as other proposed changes that may require regulatory inputs.
  • Provide regulatory input in quality system assessments, non-conforming material evaluations, recalls and field actions, complaints/MDR/Vigilance, as well as other post marketing surveillance systems.
  • Assist with development and maintenance of Clinical Evaluation Reports in conformance to MEDDEV 2.7.1, Maintain annual facility registrations and device listings as appropriate Maintain annual facility registrations and device listings as appropriate.

 

BASIC SKILLS/EDUCATION/EXPERIENCE REQUIREMENTS:

 

  • Bachelor s degree required, preferably in Regulatory Science, Life Sciences, Engineering, or related medical/scientific field
  • 2+ years of Regulatory Affairs medical device industry experience-Class III US
  • Thorough understanding of US regulatory requirements, EU prefffered
  • Experience with medical device labeling and promotional requirements
  • RAC certification preferred
  • Prior medical device experience from a Regulatory Compliance/Quality System standpoint
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