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Medical Regulatory Affairs Engineer

Job Title: Medical Regulatory Affairs Engineer
Contract Type: Permanent
Location: Worcestershire, England
Industry:
Salary: Negotiable
Reference: J903153_1571762634
Contact Name: Anna Khan
Contact Email: anna.khan@russell-taylor.co.uk
Job Published: October 22, 2019 17:43

Job Description

Role: Medical Regulatory Affairs Engineer

Location: Worcestershire

Salary: DOE

Russell Taylor Group have a fantastic opportunity for a Quality/Test Engineer to progress into the RA/QA sector of a global testing and inspection company. This job presents the perfect opportunity for someone who has previous experience within the medical device sector, if this is of interest to you please apply within.

Role:

  • Produce Compliance Strategy documents
  • Perform Usability and Software assessments in accordance with IEC 62366-1:2015 and IEC 62304-1:2006/A1:2015
  • Provide guidance on medical regulatory requirements
  • Advise on best practise for product-focused risk management
  • Provide expert Technical Opinions
  • Conduct Compliance Reviews
  • Build relationships with customers by offering on-going support services, and supporting the medical products testing team

Person:

  • Experience within Medical Device (ISO 13485) and electronics is essential
  • Previous experience working with IEC 62366-1:2015 and IEC 62304-1:2006/A1:2015 would be advantageous
  • Background in regulatory affairs in respect to electronic products (or similar)
  • Experience in undertaking software and usability assessments to the applicable standards
  • Detailed understanding of the EU and North American medical regulatory requirements as applicable to electrical/electronic devices and software
  • Electronics or similar qualification would also be advantageous

Key Words: Medical Device, ISO 13485, Electronic, Regulatory Affairs

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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