Cyden designs and manufactures IPL (intense pulsed light) hair removal products for use in the home which are sold globally. The products are now classed internationally as medical electronic devices.

Cyden is unique in combining technological innovation with clinical understanding of skin-light interaction. The potential for home use devices is huge and as well as hair removal there are opportunities to expand the use of the technology into skin rejuvenation, acne treatment and other beauty applications. Cyden is an exciting company with a bright future ahead of it.

CyDen is growing very quickly, being included in the top 50 fastest growing companies in Wales in two consecutive years and winning the Queen’s Award for Enterprise for our international trade performance. We are investing heavily in our clinical and technical capability with the objective of diversifying our product portfolio

The Role.

Working closely with the Senior Engineering Project Manager and the engineering, operations and quality teams, the jobholder will manage and coordinate the documentation and risk management activities required to support the NPD process in line with the company’s quality system. Utilising applicable medical device requirements and developing an understanding of the products, the jobholder will become the key link between regulatory and development.

Key Responsibilities

New Product Development

  • Running the risk management program for new and current devices to IEC 14971
  • Responsible for creating and maintaining Risk Management documentation
  • Collate project files / design history and documentation for multiple projects.
  • Produce usability documentation
  • Ensure design history documentation is ready for audits
  • Write procedures and ensure their relevance
  • General administration support

Regulatory Submission

  • Co-ordinating regulatory submissions and testing
  • Liaise with external approval suppliers
  • Create in-country license documentation for regulatory submission
  • Preparing samples for submission
  • Collating information from various departments to support submission

The Person
 Essential:
– Experience of running risk management activities and procedures
– Previous experience working in a relevant highly regulated industry
– Excellent IT skills, including MS Excel and Word
– Risk management qualification
– Degree level qualification in a technical subject
Desirable:
– Previous experience in a product development environment
– Understanding of Quality Management Systems (e. ISO 9001)
– Training in ISO 14971
– Training in ISO 13485
In addition, the successful candidate will have the following attributes:
– Self-motivated and able to work independently
– Detail orientated with ability to work across multiple projects
– Clear & concise writing style
– Ability to convert technical information into easy to understand language
– Ability to work within a high growth, often pressurized environment and meet strict deadlines

To Apply: please send your CV to: recruitment@cyden.com quoting ‘Technical /DH File Management Engineer ’ in the subject line.