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QARA Manager

QARA Manager

  • Location

    Austin

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Market related

  • Contact:

    Callum Sparkes

  • Contact email:

    Callum.Sparkes@jcwresourcing.com

  • Contact phone:

    02035899300

  • Job ref:

    LM46519

  • Published:

    over 1 year ago

  • Expiry date:

    2019-08-21

  • Consultant:

    #

Are you wanting to work for a Medical Devices company that is shaking up the way healthcare is provided on a global scale? Tired of working on general maintenance of regulatory files for products that have no way to develop? Looking to work for one of the most talked about start-ups in the medical world right now?

Well then this is the opportunity for you!

What experience you can expect to gain:

  • Set up and consult with the senior management on the regulatory systems and strategy for the company’s short and long terms future.
  • Support the product development teams in the implementation of regulatory requirements, including preparation and review of design and test documentation.
  • Perform regulatory assessment of product changes.
  • Coordinate all activities related to domestic and regulatory submission and approval for medical software solutions.
  • Prepare, coordinate, and file regulatory submission documents.
  • Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
  • Prepare, or contribute to the preparation of post-market surveillance plans and evaluate post-market data.
  • Drive regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
  • Ensure regulatory requirements are met for maintenance of products.
  • Stay abreast of current and novel developments in the field.
  • As part of a new start-up with a highly collaborative culture, perform other related duties and “pitch in” where needed.
  • Support internal and external audits.
  • Research and evaluate different risk factors regarding business decisions and operations.

What experience will best serve you:

  • Bachelor’s degree or higher.
  • 3 to 5 years of proven regulatory experience with class II or III medical devices, and FDA approval for 510k, de Novo for software as a medical device
  • Knowledge of the QMS ISO:13485, and MDSAP.
  • Experience with new product development standards and documentation for software products.
  • Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
  • Strong organisational skills; ability to remain organised and productive in fast-paced work environment with competing priorities.
  • Work independently, diligently, and efficiently on assigned tasks and projects.
  • Collaborate seamlessly with teams.
  • Ability to review and provide critical feedback on design documentation.
  • Ability to communicate and interact with regulatory agencies and consultants.
  • Excellent English written and verbal skills.
  • Strong technical presentation skills.