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Regulatory Affairs Specialist

Real Staffing
Job LocationCambridge
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Regulatory Affairs Specialist (Medical Devices)Our client is a medical device company who operate globally and are currently hiring for their site in Cambridge. They market and develop chemical disinfectants and have seen rapid growth within the infection control industry.PositionThe Regulatory Affairs Specialist will be responsible for companys products to meet legislative requirements. You will have the responsibility and authority to ensure gathering, evaluation, organisation, communication and understanding of information relatingto Regulatory requirements for new and existing products. Also the Regulatory Affairs Specialist will offer technical support to customers and staff regarding both products and legislations.Responsibilities

  • The Regulatory Affairs Specialist will participate in project teams to provide regulatory input into cross departmental product development and international registration projects.
  • Assist marketing in preparing product manuals or technical materials upon request, advise marketing on labelling, literature and advertising regulatory requirements.
  • Prepare documentation and product registration dossiers.
  • The Regulatory Affairs Specialist will create and maintain product technical files and product design dossiers.
  • Work alongside the European Authorised Representative, Sole Representative, Sponsors, in all matters concerning their requirements under applicable local standards, directives and regulations.
  • Maintain and update existing worldwide authorisations, acting as the companies representative.
  • The Regulatory Affairs Specialist will develop study definition and design to obtain validation and verification data; commission studies with subsequent collation and recording of data and report in readiness for the preparation of applications to regulatoryauthorities.
  • Develop strategies and prepare documents for products marketed globally for the preparation of applications to regulatory authorities.
  • Support, author, and view the writing of SOPs and work instructions related to medical device products, risk assessment, review of data from physical-chemical, efficiency and in-vitro testing to maintain compliance.
  • The Regulatory Affairs Specialist will ensure that the business goals are achieved in adherence to all relevant regulatory requirements.
About you
  • Ideally, knowledge of working regulatory requirements in UK, EU, USA, Canada, Australia, China and other world regions.
  • Able to work in an IVD, medical device or pharmaceutical environment.
  • Ideally a Scientific background.
  • Knowledge of compliance to Quality Management Systems.
To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

Keyskills :
ChemistryMedical DevicesRegulatoryIVDTechnical FilesISO 9001ISO 13485Global SubmissionsBiocidal

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