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Permanent

Sr RA Specialist

  • Location

    Other Locations

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    27392

  • Contact

    Alex Williams

  • Published

    19 days ago

Expired job

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Overview

Primary Function

The Sr. Regulatory Affairs Specialist is a key contributor to the company's regulatory group focused on support for AVITA Medical's regenerative products. The role includes providing early guidance, review, and approval of submission-related documentation.

Duties/Responsibilities

  • RA lead for all activities associated with changes to the on-market product (supplier, design, manufacturing, etc.)
  • Assesses changes for any regulatory action required in the US, EU, AU/NZ, and Japan
  • Prepares FDA submissions (PMA supplements) to ensure timely approvals and market release for product changes
  • Establish and manage documented procedures for the creation and management of IFUs, procedure guides, and product labels
  • Define Labeling content in compliance with US and international regulatory requirements
  • Reviews and approves product testing and other submission related deliverables to ensure regulatory compliance
  • Collaborates with new product development team and provide regulatory support as required
  • Reviews and Revises SOPs, and other company and departmental procedures to ensure quality system compliance
  • Participates in device development design reviews and risk management activities
  • Establishes and maintains relationships within AVITA Medical quality, R & D, and operations teams



Special Knowledge/Skills

  • Experience in the development of FDA submissions for a medical device (IDE, 510 (k), HDE, PMA, or PMA supplements)
  • Experience in reviewing and/or approving engineering reports/data or changes
  • Ability to process complex technical reports into understandable summaries
  • Ability to effectively manage multiple projects and priorities



Experience/Education

  • Degree in engineering or physical/biological sciences
  • 3+ yrs of professional work experience in regulatory affairs
  • Experience in Class III medical device industry (preferred)