Regulatory Submissions (Study Start-up) Manage Medical Devices

Regulatory Submissions (Study Start-up) Manage Medical Devices

  • Emplacement

    London, England

  • spécialité:


  • Type d'emploi:

    Durée indéterminée

  • Un salaire:

    up to 20% bonus

  • Contact:

    Denise Saab

  • Email du contact:


  • Référence du poste:


  • Publié:

    plus d'un an

  • Date d'expiration:


  • Date de début:


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.

We are seeking a full-time Regulatory Submissions (Study Start -up) Manager, on their Medical devices area who will work on a team to accomplish tasks and projects that are instrumental to the company's success

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.

*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
*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