Intersurgical is a thriving innovative medical manufacturing company and a world leader in providing plastic disposable products for the respiratory care business.
Position: Standards Compliance Coordinator
Location: Head Office (Wokingham UK)
Job type: Full Time, Permanent
Hours: 40 hours per week, Monday – Friday, flexible start and end times
Salary: £20,000 - 30,000 per annum
About the role:
An exciting opportunity has arisen at Intersurgical for a Standards Compliance Coordinator to join our thriving UK medical device manufacturing company.
The successful candidate will be joining the team reviewing applicable BS EN and ISO medical device Standards to ensure current and new products within the Intersurgical range are state-of-the-art and compliant with the Medical Device Regulations.
- To create and maintain standards compliance data sheets.
- To assist in conducting strategic analysis on proposed new and revised standards.
- To be proactive in suggesting improvements to standards process.
- To support the electronic standards database.
- To create improved links teams.
- Good communication and people skills.
- Self-motivated and willing to learn.
- Excellent attention to detail.
- Methodical, organised and structured approach to work.
- Able to multitask and prioritise workload.
- Ability to work effectively as part of a team.
- Science related qualification.
- Interest in Medical Devices.
- Experience with Technical Regulatory Documentation.
- Knowledge of BS, EN, ISO Standards.
- Knowledge of MDD 93 / 42 / EEC, IEC 60601 and FDA Control.
You may have experience of the following: Standards Compliance Coordinator, Compliance Coordinator, Regulation, Regulatory, ISO, Compliance Officer, Compliance Co-ordinator, Technical Standards, Compliance Management, Product Compliance, etc.