Regulatory Affairs Associate

• Reference: JLSQR
• Location: South Wales
• Salary: £50k+
• Type: Full time
• Start: ASAP

Just Life Sciences are seeking an experienced Regulatory Affairs Associate, for the Global Client in South Wales. The role will be Hybrid yet you willl be expected to be in the office for 2 days a week.
The Regulatory Affairs Associate will assist the Director of Regulatorywith all the technical aspects of Regulatory Affairs including but not limited to compilation, submission and maintenance of the registrations and technical documentation in accordance with the country specific requirements to relevant Regulatory Authorities

Qualifications, Skills and Experience

• Responsibilities
  • To maintain the relevant Global, local Regulatory and compliance databases
  • Be responsible for maintenance and preparation of technical documentation, including labelling and information to be provided, as well as preparation of registration documents for IVDR, FDA, CE, UKCA
  • Prepare and submit regulatory submissions to global regulatory authorities as required for global approvals for in vitro diagnostic (IVD) products (FDA, CE, UKCA) as a legal manufacturer and also for PLM customer, including preparation of documents (such as Technical Files and artworks) and interaction with regulatory officials as required.
  • Provide ongoing regulatory advice to project teams throughout product and process development, ensuring regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives
  • Ensure that all company's products comply with the regulations of the regions where sold
  • Keep up to date with national and international legislation, guidelines and customer practices
  • literature researches on legal requirements for territory registrations and regulatory affairs updates
  • Conduct Post Market Surveillance activities by collecting, collating and evaluating scientific data from a range of sources.
  • Support performance evaluation studies for new product development and current marketed products
  • Communicating with customers throughout the project lifecycle
  • Prepare product submissions to strict deadlines
  • Work with specialist computer software and resources e.g. EUDAMED
  • Write clear, accessible product labels and instructions for use
  • Advise scientists and manufacturing on regulatory requirements
  • Review company practices and provide advice on changes to systems including introduction of new processes.
  • Actively participate in global external audits in relation to ISO, MDSAP, FDA, IVDR, notified bodies and/or regulatory inspections.
  • Maintain regulatory procedures and processes.
• Interested then please email your CV to justyn@justlifesciences.com
  

Apply Now

• Just Life Sciences

  • 2a Foster Drive,
    Cardiff,
    CF23 9BZ
  • Mobile 07968 551450
  • Email justyn.withey@justlifesciences.com
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