W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9jbhnyzxnvdxjjaw5nig5ldy9qcgcvbmv3lwjhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    London

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    £50k - 60k per year

  • Contact:

    Jack Clay

  • Contact email:

    Jack.clay@catalystcareers.com

  • Contact phone:

    02035899300

  • Job ref:

    LM46262

  • Published:

    about 1 year ago

  • Expiry date:

    2019-10-01

This opportunity is for someone who is looking to work on disruptive technology in the Medical Devices industry that is going to revolutionise the way healthcare operates on a daily basis, and global scale.

If you want to be part of one of the fastest growing healthcare businesses on the planet, working on the Regulatory goals of the company in order to help the product realise its full potential, then this is for you!

You're going to be:

Supporting country registrations in EU: Maintaining current approvals, obtaining approval in targeted countries

Establishing and maintaining technical files for CE Marking

Supporting country registrations in Asia/China: Provide appropriate requested documentation from China

Participating in risk management reviews and assessment of complaints

Advising on regulatory strategy for new products or product features

Managing, planning and submitting regulatory submission documentation in different countries and with partners

Working closely with Regulatory Authorities for submissions, listings, incident reporting etc.

Monitoring regulatory developments and provide regulatory intelligence for Software as a Medical Device (SaMD)

Reviewing plans, FMEAs, verification and validation protocols and reports

Developing regulatory strategy for registration activities

Providing regulatory input to product lifecycle planning

Determining and communicating submission and approval requirements

Supporting labelling activities (including IFU). Assisting with label development and reviewing for compliance

Preparing and submitting annual reports, as required by international regulations

Maintaining regulatory SOPs and review

Reviewing and approving Document Change Notifications; reviewing for regulatory compliance and for impact on submission

You're going to need:

3+ years' experience as a Regulatory Affairs Manager or lead within Medical Devices, working autonomously

Software experience desirable