Hobson Prior are looking for a Regulatory Affairs IVD Manager to work remotely for one of the world's leading specialised medical diagnostic companies, where you will take the lead in growing their Regulatory affairs department.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Lead, manage and organise a team of Regulatory Affairs professionals for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM.
• You will represent the company for 3rd party submissions for FDA, Notified Bodies and global regulatory authorities.
• Support key development projects to meet strategic business objectives.
• Manage global submissions including EU, FDA.
• Represent Regulatory Affairs in product development projects.
• Support Internal audits.
• Represent Regulatory Affairs in 3rd party audits - MDSAP, FDA.
• Support department in maintaining company compliance to QMS requirements - MDSAP.
• Planning activities to support budget and headcount.

Requirements:

• A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.
• At least 2-5 years of supervisory or management QA/RA roles in healthcare industry (IVD).
• Post graduate qualification in Regulatory Affairs.
• Management or supervisory in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent.
• Regulatory Affairs and / or Quality assurance background.
• Awareness an interest in wider RA environment - IVDR, Brexit, FDA, RAC, MedTech Europe.
• Membership of TOPRA, BIVDA.
• Experience of leading teams or projects in a regulated industry.
• FDA submissions experience for PMA, 510k, pre-submissions.
• Product development, design controls.
• Lead auditor experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.