Sysmex UK are looking to recruit a Regulatory Affairs professional who has a scientific background within the IVD sector to join our highly successful team. In this role you will develop processes and systems to help ensure that Sysmex UK are meeting all our local regulatory requirements.
With support from our Regional Headquarter regulatory teams and local Product Managers you will support and lead on Sysmex UK’s regulatory activities and requirements associated with new product release requirements, UK MDR2002, IVD-R 2017, UK REACH, CLP, Product labelling, Product registration, post market surveillance and management of adverse incidents.
Regulatory Affairs Specialist
- Write and analyse technical documents to support regulatory submissions. (e.g. CLP, SCIP, Waste Disposal)
- Maintain technical files used for UKCA MHRA registration.
- Complete UKRP registrations and maintain appropriate documentation.
- Risk assess and investigate reports of adverse incidents in relation to post-market surveillance.
- Monitor trends in adverse incidents related to post-market surveillance.
- Respond to questions from regulatory authorities professionally and within agreed timelines.
- Monitor and report on progress of safety corrective actions (FSCAs).
- Manage the company Plastic Packaging Tax requirements, including collating and maintaining supporting material component evidence.
- Minimum of 3 years demonstrated ability within the Regulatory Affairs area
- Hold a bachelor’s degree in a technical or scientific field
- Strong analytical / critical thinking skills with the ability to multitask.
- Have a high level of integrity, initiative and self-motivatio
The successful applicant will be home based however will need to come to the office one day a week.
This role is eligible for our extensive company benefit package.
We can only accept direct applications from candidates if they have a valid right to work in the UK & Ireland.
