Medical Devices Regulatory Engineer (ISO13485, 510(k))

Recruiter
We Are SSG
Location
Alcester
Salary
Competitive
Posted
18 Oct 2019
Closes
25 Oct 2019
Sector
Engineering
Contract Type
Permanent

Medical Devices Regulatory Engineer (ISO13485, 510(k))

Warwickshire

GBPNeg + benefits

This is a fantastic opportunity for a Regulatory Engineer to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market.

Responsibilities

  • Ensure that the Technical File created as a requirement for the company's CE status is maintained.
  • Assist with regulatory compliance in other markets to which devices manufactured by the company will be introduced.
  • Provide support with the application for the FDA 510(k) process.
  • Provide assistance in the application of market specific QMS requirements e.g. ISO 13485, FDA 21 CFR Part 820 etc.
  • Ensure that all standards associated with manufactured devices are maintained to the latest issue.
  • Maintain and initiate new clause compliance documents based on the standards and directives applicable to the markets in which devices will be introduced.
  • Ensure that potential future changes to the standards and the MDD are understood and transmitted to relevant personnel to ensure products are future proofed.
  • Selection of suitable strategy for all market submissions.
  • Selection of suitable strategies for regulatory submissions in all markets.

Experience

  • FDA submission, specifically 510(k) and the selection of predicate devices.
  • Medical devices and the 510(k) process.
  • The construction and maintenance of a Technical File as required for CE.
  • Experience with the implementation of the MDD.
  • Science or Engineering degree, or relevant experience.
  • Working with Medical devices/high specification device.