£50k - 60k per year
5 months ago
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