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Job Details

Regulatory Affairs Specialist - £40-50k – Cambridge – Medical Devices, IVDs

Company: Meet
Location: Cambridge, Luton, Northampton, Peterborough
Reference: NB-RA-Camb
Closing Date: 24 Aug 17
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

The company are a niche IVD medical device manufacturer who sell their products not just in the EU, but all over the world. They have seen significant growth year on year and aren’t looking to stop now. The global trend towards specific IVD regulation, a recent update to EU regulation and a company strategy to move into the US have led to increased demand on regulatory resources.

Requirements:

Regulatory Affairs Specialist, £40-50k, Cambridgeshire, Medical Devices, IVDs

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Key Responsibilities:

  • Regulatory registration and submissions
  • Co-ordination of performance evaluations and validations
  • Maintaining company’s technical files
  • Risk Assessments

Tasks and Accountabilities:

  • Requirements for regulatory submissions
  • Collation of technical file documentation such as risk assessment summaries and product specifications
  • Liaising with distributors to assist with registrations and any necessary paperwork to facilitate importing company’s products.
  • Legalisation of documents
  • Coordination of detailed risk assessments

Skills Required:

  • A background in a science related subject as well as experience of working in a regulated medical device or IVD environment.
  • Experience of working to ISO 13485 and CFR 820 quality systems would be an advantage. 
  • The candidate should also have experience of technical file documentation and risk management.
  • Experience with documentation for regulatory submission such as for FDA or CE marking is highly desirable.

Full job description and company details are available upon application, apply below. This position is being dealt with by Nathan Berkley at Meet, please call 0203 019 6020. You can also e-mail us directly at nathan@peoplewithchemistry.com to discuss in confidence.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at www.peoplewithchemistry.com

Key Words

21 CFR (820, 210 and 11), MDD (93/42/EC), IVDD (98/79/EC), ISO 13485, Medical devices, Regulatory Affairs, Regulatory Affairs Officer Jobs, Regulatory Affairs Specialist Jobs, Medical Device Jobs, Regulatory Affairs Associate Jobs, Regulatory Affairs Associate, Regulator Affairs Officer, Regulatory Affairs Specialist, Medical Device, Cambridge, Cambridgeshire, Milton Keynes, Luton, Northampton, Peterborough

Apply for this job: Regulatory Affairs Specialist - £40-50k – Cambridge – Medical Devices, IVDs

Contact Information:

Address:  meet
Irongate House, 30 Dukes Place, London
EC3A 7HX
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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