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Regulatory Submissions (Study Start-up) Manage Medical Devices

Job Title: Regulatory Submissions (Study Start-up) Manage Medical Devices
Contract Type: Permanent
Location: London, England
Industry:
Salary: up to 20% bonus
Start Date: ASAP
Reference: 73477-PHARM-DEB_1551701684
Contact Name: Denise Saab
Contact Email: Denise.Saab@volt.eu.com
Job Published: March 04, 2019 12:14

Job Description

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