CyDen is a British Health and Beauty company and the leading developer of intense pulsed light (IPL) hair removal devices for use in the home. Our electronic beauty products are distributed worldwide into household and medical markets under globally recognised brand names.
CyDen provides a dynamic and exciting working environment, supported by an excellent and welcoming team of employees. We are looking for the right person to join our team based in Swansea.
This is a great opportunity for an organised and enthusiastic Regulatory Engineer to join one of the leaders in light-based hair removal.
The Regulatory Engineer will carry out the following tasks:
- Collaborate with Cyden and customer regulatory teams to determine the global device classifications for new project lines
- Support the registration activities for new medical device submissions
- Maintain global regulatory certifications and compliances for existing device lines
- Develop a detailed knowledge of test and safety standards to comply with the international regulatory marking requirements for international launches
- Prepare and deliver initial device submission samples to regulatory test bodies for review and evaluation
Full product and regulatory territory training will be provided.
- HNC/HND Electrical/Electronic Engineering
- Excellent written and verbal communication skills
- Excellent accuracy and attention to detail
- Capable of working on multiple projects, both independently and in a team environment
- Able to critically evaluate and summarise complex data into simple messages and actions
- Prepared to build networks and alliances with peers and external partners
- A degree in a relevant scientific discipline, or equivalent experience
- Regulatory experience within medical devices
- Working knowledge of ISO 13485
The successful candidate will be efficient, well organised and have a systematic and methodical approach to their work. They will have a positive and motivated attitude
Salary and Benefits
- Competitive salary of up to £25,000 depending on experience
- 25 days holiday
- Childcare Voucher scheme
- Cycle to Work scheme
- Free parking
To Apply please send your CV and a cover letter via email quoting ‘Regulatory Engineer’ in the subject line.
The closing date for applications is 9th of April