Regulatory Affairs Project manager
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If?the answer is 'yes’ then you’re just the kind of person we’re looking for!
We are looking for a Regulatory Affairs Project Manager who is organised, experienced, passionate individual to work in our busy Regulatory affairs department.
The Regulatory Affairs Project Manager will be responsible for organising and managing all new product launch's projects for global markets including EU, USA, Asia, LATAM.
This role is REMOTE and can be based anywhere within the UK with Head office based in Birmingham.
The Roleincludes: -
- To organise 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
- 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
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.
Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Hours: 40 hrs (5 days remote working)
- Competitive Salary
- Contributory Pension
- 25 days paid holiday plus bank holidays