Regulatory Affairs Specialist

You will develop processes and systems to help ensure that they are meeting all their local regulatory requirements.
You will support and lead on our clients 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.
You will also be expected to assist the Business Management System team in other regulatory requirements that relate to our client.

Our client is a leading global IVD manufacturer specialising in Haematology and Haemostasis disciplines. They are responsible for the importation, distribution and support of IVD equipment throughout the UK and Ireland whilst demonstrating alternative growth by diversification into distribution of third-party product lines and through Managed Service Contracts.

Minimum of 3 years demonstrated ability within the Regulatory Affairs area.
Hold a Bachelor’s degree in a technical or scientific field.
Have a high level of integrity, initiative and self-motivation.
Strong Microsoft Office skills.
Ability to identify compliance risks and escalate when necessary.

Qualifications and Experience – Desirable Requirements
Experience within the IVD industry.
Experience with product registration.
Experience with EU and UK REACH compliance.
Documented training on current medical device standards and regulations (e.g., UK MDR, ISO 13485, etc.).
Postgraduate qualification to PhD/MSc standard.

Competitive basic salary (depending on level of experience).
12% bonus .