Product Development Manager - IVD

Product Development Manager - IVD
  • Competitive
  • Permanent
  • Cambridge, Cambridgeshire, England, UK CB2 3AR Cambridge Cambridgeshire UK CB2 3AR
Job Ref: J2161151
Sector: Science
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 13 July 2021
Product Development Manager

Product Development Manager - IVD/Medical Devices



£ Competitive, commensurate with experience, skills and background

Scope of the role:

Lead on the scientific development, validation and efficacy of an IVD by utilising next generation sequencing in order to bring the device forward for commercialisation. Taking a multidisciplinary approach, you will work closely with regulatory, quality, clinical and R&D teams in both a hands-on laboratory, and project management capacity. This role offers a unique blend of both the regulatory and the practical elements of building a game-changing diagnostic device for the progression of treatment in the gastro-intestinal oncology space.

Role requirements:

  • Support with the technical and process-driven activities for IVD certification to guarantee UKCA and CE compliance

  • Project management from conception including the objective and requirements, to development process, and commercialisation. Take responsibility for management of internal and external teams, suppliers and resources

  • Monitor and report to the stakeholders in the business, the status of each project, suggesting and implementing methods for improving deliverables
  • Presenting scientific data and reports for senior level team meetings

  • Preparation of the risk management file, taking the lead on risk management activities

  • Plan and suggest the design for validation and verification testing of the devices

  • Prepare technical reports, and work closely with the R&D team to obtain technical documents required for designated regulatory workflows
  • Ensure on-time and in-budget delivery of project milestones with an awareness for the global bigger picture and how your input supports the end goal

Your background:

  • Demonstrable product development background within the IVD sector, or medical devices

  • Sound understanding of ISO 13485, CE marking, IVD, MHRA and FDA directives

  • A background as a Scientist at the bench, within IVD/medical devices (this could be manufacturing, production, R&D or V&V for example)

  • BSc or equivalent in a scientific discipline

  • Effective and accurate communicator in verbal and written English, able to prepare clear and concise regulatory and quality documentation

  • Quality Management experience

  • A broad background in working with the design and manufacture at commercialisation of a range of different IVD's across different risk classifications

  • Solutions oriented, excellent analytical skills, ability to prioritise with excellent planning and organisation skills

  • IT literate, especially with reference to project management packages such as PRINCE2 or MS Project, Excel and PowerPoint

12/08/2021 15:28:40
GBP Annum
Contact Consultant:
Bec Johnston2

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