Devices Regulatory Submissions Manager - Scotland

Recruiter
Planet Pharma Staffing Limited
Location
United Kingdom
Posted
26 Sep 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Requirements: 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. Strong oral and written communication skills. Job Title: Devices Regulatory Submissions Manager Location: Scotland Benefits: Successful candidates can enjoy all the benefits associated with working for a global company including a COMPETITIVE SALARY and EXCELLENT TRAINING Job Description: 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 defenses, general capabilities meetings, and audits. About Planet Pharma Planet Pharma is an American parented, global staffing organisation head-quartered from Chicago with our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. To apply If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone either Chiara on +44 (0)20 3318 9376 or e-mail on czentile@planet-pharma.co.uk If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help! Keywords Medical Devices, Scotland, Clinical Research, CRO, Submissions