Regulatory Affairs Specialist

Birmingham - Calthorpe Road
Description

 

Regulatory Affairs Specialist 

 

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 Specialist who is organised, committed, methodical, passionate individual to work in our busy Regulatory affairs department.  

 

Alongside team management, the Regulatory Affairs Specialist is responsible for assisting in all global regulatory affairs activities to contribute to overall company objectives.  

 

This role is REMOTE and can be based anywhere within the UK with Head office based in Birmingham. 

 

The Role includes: - 

  • To assist in regulatory affairs projects for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM  
  • Support key development projects to meet strategic business objectives. 
  • Assist in global submissions including EU, FDA   
  • Assist in vigilance and post market surveillance activities.  
  • Regulatory review-controlled documents. 
  • Support regulatory compliance for QMS to meet requirements, including MDSAP and IVDR 
  • Support 3rd party audits 

 

Experience required: - 

  • A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.  
  • Several years in QA/RA roles in healthcare industry (pharma, medical devices, or diagnostics 
  • IVD industry experience  
  • Global registration 
  • R&D clinical, production research & development 

 

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 - Office base Birmingham

Hours: 40 hrs 

Benefits: 

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