Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.

Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry. 

To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:

• Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
• Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
• Have experience in interacting with external partners and regulatory agencies including the FDA.
• Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
• Have supervisory experience.
• Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.

How to apply

For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk.