Job Description

We are looking for an Regulatory Affairs Project Manager who is organized, experienced, passionate individual to work in our busy Regulatory Affairs department.

• To organize and manage regulatory affairs projects for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM
• Represent 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 RA in product development projects
• Provide leadership and guidance on regulatory issues and ensure regulatory requirements are well understood and communicated
• Support Internal audits
• Represent RA in 3rd party audits – MDSAP, FDA

Required Knowledge, Skills, and Abilities

A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent. New FDA Product Management. 2-5 years of supervisory or management QA/RA roles in healthcare industry (IVD). Post graduate qualification in Regulatory Affairs. 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, presubmissions IVD industry experience. Product development, design controls, Lead auditor experience.