Regulatory Affairs Advisor / Quality and Regulatory Affairs AdministratorHorsham, £22,000 - £35,000 Permanent
£22K - £35K basic, depending on experience + Benefits.
Our client produces world class software for the Life Science Scientific Sectors. Due to growth in the business they are now looking for a Quality and Regulatory Affairs Specialist / Administrator to join our dedicated team in Horsham.
Our client fosters a close-knit, professional and very friendly culture, They are committed to developing and investing in their people, so you will have plenty of support to hone your skill-set and pursue your professional ambitions.
As a Quality and Regulatory Affairs Specialist, you will be tasked with driving standards with the organisation. Specifically, you will ensure that we operate in-line with ISO, medical devices regulations and other ISO standards.
• Manage, maintain day to day operations and promote of the Quality Management System (QMS) – ISO 9001, ISO 13485, MDD (MDR).
• Making sure that the medical devices produced conforms to regulatory requirements of MDD (to be replaced to MDR), MDSAP (Canada only) and FDA regulations and hosting any regulatory inspections.
• Applicant will also be responsible for raising CAPAs (including maintaining and performing internal audits), implementing corrective actions and making sure that any preventative actions are incorporated and reviewed to be assessed for effectiveness.
• Within the role there will be some travel to a sister company in Guildford in assisting them to review their quality system and to bring it into line with the Group. Furthermore there is the possibility in the future to assist with the internal auditing in the office in the US.
• The position will report to the Group Quality Director based in South Yorkshire so you will have the ability to work independently, be tenacious and pragmatic in your work. You will have excellent attention to detail and be flexible.
• The ideal candidate will ideally have a degree in a Science based subject and have performed audits in a previous role/position and be familiar with ISO 9001 and Medical Devices or have worked with Medical Devices and would prefer to be involved more with the quality aspect.
• We would also welcome Science Graduate who have some experience in Audit and Compliance work.
Due to the amount of applications we receive, unfortunately we are not able to give feedback to all candidates, if you have not heard back within 5 days please assume that you have not been successful for the role you have applied for. We will hold your details on our database and consider you for future opportunities, unless you instruct us otherwise. Good luck with your job search. Many thanks - Pyramid8 Ltd.