Regulatory Affairs Manager

Birmingham - Calthorpe Road
Description

Regulatory Affairs 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 Manager who is organised, experienced, passionate individual to take the lead in our growing Regulatory affairs department.  

 THIS ROLE IS REMOTE BASED WITH OCASSIONAL TRAVEL TO OUR HEAD OFFICE IN BIRMINGHAM

The Role includes: - 

  • Lead, manage and organise a team of Regulatory Affairs professionals for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM. 
  • 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. 

Experience required: - 

  • A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.  
  • 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, presubmissions 
  • 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. 

 

Location: Remote with travel to Head Office in Birmingham 

Hours: 40 hrs (5 days remote working) 

Benefits: 

  • Competitive Salary
  • Contributory Pension
  • 25 days paid holiday plus bank holidays
  • Medicash- taxable health benefit