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Regulatory Affairs Specialist

Radar Recruitment
Job LocationDartford
EducationNot Mentioned
Salary30,000 - 40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

We are exclusively partnering with a growing business within the medical device sector to recruit for a Regulatory Affairs Specialist as they seek to expand their offering to the market, working with a range and classification of devices.The Regulatory Affairs Specialist will have an important role to play in supporting the regulatory strategy for the business. You will ensure Technical Files are managed under the correct conformity routes and kept up to date with the changing landscapesof the medical device industry, namely EUs Medical Device Directive (93/42/EEC), EU Medical Device Regulation, (MDR (EU) 2017/745) and UK MDR 2002. The Regulatory Affairs Specialist will also provide support to achieve successful audits and manage regulatorysubmissions.The key responsibilities for the Regulatory Affairs Specialist will involve the following:

  • Compiling electronic and scanned technical file for current product portfolio
  • Creation of technical files for emerging product portfolio
  • Provide support for all audits
  • Assist in technical, quality, and regulatory issues as they arise throughout the product life cycle.
  • Write Standard Operating Procedures (SOPs)
  • Write change controls
  • Co-ordinate with Project Managers to assist in artwork control
  • Working with a range of suppliers/contactors to gather data in support of development of medical device technical files
  • Working within organisation to develop new products
The ideal candidate for the Regulatory Affairs Specialist role will have the following background:
  • Experience working within Regulatory Affairs in Medical Devices.
  • Experience witth technical files and a through knowledge of ISO 13485.
  • MDR knowledge and experience will be key to support during the MDR transition phase.
  • A very good knowledge of Medical Devices Directive 93/42/EEC (MDD) as well as Medical Devices Regulation 2017/745 (MDR)
  • A proactive and hands-on approach to working with and implementing Quality Management Systems.
Keywords: Regulatory Affairs Specialist, RA, RA/QA, QA/RA, Regulatory Affairs, 21 CFR 820, MDR

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