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Job titleRegulatory Affairs Specialist
Job typeMeditech
Salary GBP
LocationUK West
Bonus PackageBonus Package
Job description

Are you wanting to progress into the next stage of your regulatory career? Do you want to work for one of the top 5 global medical device companies? Our client is looking for a Regulatory Affairs Specialist to join their team in Berkshire.
 

The company 

Our client is a dominant market leader in providing solutions that improve medical discovery, diagnostics, and delivery of patient care. Their core focus is on making sure healthcare professionals, pharmaceutical providers and industry partners have the innovative technologies to help advance clinical therapies for patients, clinical process, and workflow. 
 

The role 

As Regulatory Affairs Specialist, you will look to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations.  

Other responsibilities include: 

  • Maintaining high level of quality and compliance in technical documents  

  • Reviewing product changes, labelling, claims and product complaints  

  • Developing regulatory strategies for product release 

  • Assessing changes in regulations help determine their impact to the business  

  • Supporting transition of products from technical files to technical documentation  

  • Preparing regulatory dossiers submission  
     

The requirements 

You will have proven regulatory affairs experience within the medical technology industry or equivalent, as well as… 

  • Bachelor’s degree in scientific or engineering discipline  

  • 5+ years of regulatory affairs experience  

  • Good working knowledge of Design Control, Software Life Cycle, and Risk Management  

  • Sound knowledge of the regulatory framework relating to Medical Devices such as the MDD and MDR CE Marking 

  • Demonstrable compliance experience with Class IIa/IIb – MDD/MDR medical devices 

  • An enthusiastic teammate, and agile in a complex and fast evolving environment  

 

Important information 

FMC contact for this role: Natasha Szombara (natasha.szombara@fmctalent.com) 

Reference number: 10873 

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    Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.