Location Cheltenham
Job-type Permanent
Salary £35k - 50k per year

Compliance Engineer

Cheltenham

My client is designs and manufactures of specialist equipment and is a solutions provider for people or organisations which require complex care. They design, develop and manufacture paediatric medical equipment. Their products are primarily focused on washing, bathing, changing and handling solutions that directly improve people’s lives. We have been established for over 25 years but are now heavily investing in our future as we look to expand.

Their product line is continually evolving and growing. They require a compliance engineer to help us navigate our regulatory requirements for new and existing products. If you have 4 or more years of experience in a regulatory, compliance or standards engineering role and want to help create products that directly improve people’s lives, then this is a perfect opportunity.

Requirements

  • A relevant degree i.e. engineering, medicine or another relevant scientific discipline or 4 + years’ experience in a compliance or regulatory affairs role.
  • Understanding of regulatory requirements for the Machinery Directive or Class I medical
  • devices to MDD and/or MDR.
  • Ideally experience of some of the following ISO9001, ISO13485, IEC60601, ISO14971.
  • Proactive, organised, self-starter & passionate about standards.

Responsibilities

  • Technical Content File creation, maintenance and ownership.
  • Support product classification levels of medical & machine products.
  • Review and maintenance of existing product requirements to latest standards.
  • Product level risk assessments to ISO14971.
  • dFMEA & pFMEA product ownership.
  • Keeping up to date with latest standards & product requirements.
  • Assist with compliance and standards requirements setting for new R&D projects.
  • Ensures that documentation, drawings, labels, manuals, etc. are accurate and consistent.
  • Potential for writing industry first white papers and new standards

For more information please call Giles Churchill at Omega Resource Group on 01453 829794 or 07966 971648