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Regulatory Affairs – Medical devices

East Midlands   •  Very attractive  •  Permanent, Full time

Our client is seeking an enthusiastic and well-organised individual with experience in medical devices.

The key responsibilities involve provision of technical and administrative regulatory support for new medical device product submission and evaluation.

Duties include but not limited to:

  • Provision of regulatory compliance requests from internal and external clients and reporting product information.
  • Collection and use of data on departmental performance to make recommendations for continuous process improvement.
  • provision and maintenance of product information databases
  • Research and reviewing information about the products
  • Reviewing and responding to customer specification requests.
  • Maintaining and updating reference materials to assist departmental employees’ responses to customers
  • Monitoring product changes to assure compliance with domestic and foreign regulatory requirements.
  • Obtaining and distributing updated information regarding international laws and guidelines.
  • Maintaining current knowledge of existing and emerging regulations
  • Reviewing product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
    Masters or PhD in material science, engineering, Chemistry or related sciences.
    Experience and good knowledge (minimum 2 years) of regulatory requirements for medical devices or similar products
    Working knowledge of statistics and electronic documentation and information systems
    The Candidate will demonstrate excellent communication skills and the ability to work individually under own initiative as well as within a group
    All applicants must be eligible to live and work in the UK
  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737 241823
  • Reference: BLR12
  • Updated: 21st December 2018
  • Expires: 18th January 2019

ST Recruitment

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