Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Regulatory Affairs Project manager

The Binding Site
Job LocationEdgbaston
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Regulatory Affairs Project ManagerWould you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovationDo you want to make a differenceIfthe answer is yes’ then you’re just the kind of person we’re looking for!We are looking for a Regulatory Affairs Project Manager who is organised, experienced, passionate individual to work in our busy Regulatory affairs department.The Regulatory Affairs Project Manager will be responsible for organising and managing all new product launchs projects for global markets including EU, USA, Asia, LATAM.This role is REMOTE and can be based anywhere within the UK with Head office based in Birmingham.The Roleincludes: -

  • To organise and manage regulatory affairs projects for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM
  • Represent company for 3rd party submissions for FDA, Notified Bodies, and global regulatory authorities
  • Support key development projects to meet strategic business objectives
  • Manage global submissions including EU, FDA
  • Represent RA in product development projects
  • Provide leadership and guidance on regulatory issues and ensure regulatory requirements are well understood and communicated
  • Support Internal audits
  • Represent RA in 3rd party audits - MDSAP, FDA
    • Experiencerequired: -
  • A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.
  • New FDA Product Management
  • 2-5 years of supervisory or management QA/RA roles in healthcare industry (IVD)
  • Post graduate qualification in Regulatory Affairs
  • Awareness an interest in wider RA environment - IVDR, Brexit, FDA, RAC, MedTech Europe
  • Membership of TOPRA, BIVDA
  • Experience of leading teams or projects in a regulated industry
  • FDA submissions experience for PMA, 510k, presubmissions
  • IVD industry experience
  • Product development, design controls,
  • Lead auditor experience
    • Working for us:Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.Location: UKHours: 40 hrs (5 days remote working)Benefits:
  • Competitive Salary
  • Contributory Pension
  • 25 days paid holiday plus bank holidays
    • Required skills
  • FDA
  • IVD
  • TOPRA
  • BIVDA

    • Keyskills :
    IVD BIVDA

    APPLY NOW

    Regulatory Affairs Project manager Related Jobs

    © 2019 Naukrijobs All Rights Reserved