Regulatory Specialist

  • Location
    Blackwood, Caerphilly
  • Salary
    £ 40000 - £ 45000 / Year
  • Job type
    Permanent
  • Industry
    Manufacturing and Production
  • External Reference
    68684
  • Category
    Engineering, Aerospace, Automotive - Manufacturing & Production Engineering

Title: Regulatory Affairs Specialist


Location: Blackwood


Contact:


Do you want to work in a role where you aren't pigeonholed into one area of Regulatory? Are you feeling limited in your tasks and your scope? Are you an experienced Regulatory Affairs professional in the medical device industry? If yes, look no further!


The Company


Set in the heart of beautiful South Wales, this company is an award-winning business and global leader in their field that manufactures their product within their UK sites and distributes to over 60 countries.


This company has an excellent reputation having established a strong culture and working environment, often the reason for moving on is due to retirement or relocation.
Their aim is to nurture and develop their staff, so no one leaves through lack of opportunity.


The Opportunity


In this role as Regulatory Affairs Specialist, you will have the unique opportunity to be the first regulatory hire for this site.


This will give you the ability to be a pioneer for regulatory and tackle a variety of regulatory projects including product submissions into the FDA and ensuring compliance across existing and new products that the business develops.


As the lead regulatory person for the site, you will be working closely with the senior regulatory specialists across the sites who will provide you support and guidance throughout.



As Regulatory Affairs Specialist you will (not an exhaustive list):



  1. Create and update Technical Files to ensure MDR compliance

  2. Complete Regulatory Submissions into global markets

  3. Review and Approve Artwork and Labelling to ensure compliance with applicable regulatory requirements.

  4. Support the Post Market Surveillance and Vigilance processes to ensure all regulatory and compliance requirements are met.

  5. Conduct internal audits to continuously improve the business QMS and processes.


Requirements



  • 3+ years of regulatory affairs experience in the medical device industry

  • Previous experience creating and/or updating technical files

  • Experience in maintaining CE marked medical devices

  • Experience working with Notified Bodies.

  • Fluent written and speaking skills in English



Interested in a further conversation? Please send your CV to arrange a confidential career discussion.


Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder