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Regulatory Submissions (Study Start-up) Manage Medical Devices

Regulatory Submissions (Study Start-up) Manage Medical Devices

  • Location

    London, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    up to 20% bonus

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    73477-PHARM-DEB_1555631266

  • Published:

    6 months ago

  • Expiry date:

    2019-04-18

  • Start date:

    ASAP

  • Consultant:

    #

Our client is a scientifically-driven, global, full-service clinical contract research organisation (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.


The company offer a fantastic package
Pension - 3% by employee, matched by employer up to 6% - 8%
25 days holiday + bank holidays and the days over Christmas.
Life Assurance x4 times base salary
Private medical insurance
Season ticket loan
Eye test contribution of up to £25, with a contribution to glasses of up to £50.
Free onsite gym between 7am - 8pm inc swimming pool.

Responsibilities
*Efficiently manage and successfully execute all aspects of global device trial start-up according to Sponsor specifications
*Oversee regional and/or global operational team preparing submission packages
*Prepare and/or review documents for RA and EC submission packages
*Review pertinent regulations to develop proactive solutions to start-up issues and challenges
*Provide advice to sponsors and project teams on device regulations and strategies
*Present during bid defences, general capabilities meetings, and audits
Qualifications
*Life sciences degree
*More than 5 years of experience in devices clinical research.
*Essential to have knowledge and experience with Device Clinical Trial Applications within Europe.
*Advantage to have knowledge and experience with Pharmaceutical Clinical Trial Applications within Europe