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Associate RA Specialist

50428
  • Swansea
  • Permanent

Associate Regulatory Affairs Specialist – Swansea / Hybrid – Medical Device

 

About the Company:

We are looking for a candidate with experience in compliance and writing from the medical device industry to work as an Associate RA Specialist at specialist medical device company in South Wales. This role will support delivery of regulatory affairs objectives and activities for the group.

 

Responsibilities:

  • Assist with the competition on RA submissions.
  • Assist with global registrations.
  • Assist with distributor registrations.
  • Liaise with engineering, quality, operations and commercial departments.
  • Prepare and maintain EU MDR, UK MDR and US 510K technical documents.
  • Creation and maintenance of RA processes.
  • Assisting with design and implementation of regulatory tools.
  • Training.
  • Assist with clinical, post market, risk, sterilization, biocompatibility and labelling documents.
  • Assist with technical and quality related issues.
  • Participate in root cause analysis and investigations.
  • Assist with validation and qualification requirements.

 

 Requirements:

  • Degree in a relevant Scientific or Engineering discipline.
  • Experience working in the medical device industry.
  • Understanding of ISO13485, EU MDR, UK MDR, MD SAP and or US 21 CFR820.
  • Excellent written and verbal communication skills.
  • Technical writing and project management experience.
  • Ability to mange time effectively.
  • Excellent organizational skills.
Claire Collinson Client Director Regulatory, Quality & R&D Recruitment

Apply for this role

  • info@kinetica.co.uk
  • +44 (0)113 261 71 81
  • Kinetica (UK) Ltd, Floor 13, Whitehall Waterfront, 2 Riverside Way, Leeds, LS1 4EH, UK