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RA Specialist Medical Device Blackwood - Hybrid

Adecco
Job LocationBlackwood
EducationNot Mentioned
Salary40,000 - 45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Regulatory Affairs Specialist (Medical Device) Blackwood- Hybrid, £40000-£45000A brilliant opportunity for a RA Specialist, with the potential of hybrid work, to join an award-winning global supplier of everyday healthcare essentials.Role responsibilities:

  • Act as a Point of Contact for Regulatory Affairs, providing advice as necessary.
  • Creation and update of Technical Files in accordance with the established schedule and requirements of international standards and directives.
  • Completion of Regulatory Submissions.
  • Review and Approve Artwork and Labelling to ensure compliance with applicable regulatory requirements.
  • Work with the Product Management team to establish and maintain documentation to ensure that company products comply with the relevant regulations (e.g., EU Medical Device Directive, EU Medical Device Regulation, EU Cosmetic Regulation, EU Biocide Regulation,EU Personal Protective Equipment Regulation and Licensed Medicinal Product requirements).
  • In conjunction with the QA team, support the Post Market Surveillance and Vigilance processes to ensure all regulatory and compliance requirements are met.
  • Conduct internal audits to continuously improve QMS and processes.
  • Consistently drive to create and implement new and innovative ways of working.
Role requirements:
  • Educated to HNC/HND level in a relevant scientific field.
  • A minimum of 2 years practical experience in Regulatory Affairs in the Medical Device Industry working to applicable European and International standards (e.g. ISO 13485 and ISO 14971).
If you are interested in this role, please contact me on OR .Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

Keyskills :
Technical FilesAudits

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