|Location: Croydon||Salary: £40000 - £45000 per annum|
|Sector: Medical Devices||Type: Permanent|
|Contact: Matt Henocq||Job Published: 25 days ago|
Regu;atory Affairs Engineer
- Working within the QA and RA team, the Regulatory Affairs Engineer assures regulatory requirements are met for new product introduction and design changes to established products.
- To proactively support the company in achieving regulatory goals and objectives and in achieving and maintaining the necessary regulatory clearances.
- This position provides and contributes to the delivery of regulatory deliverables from internal research and development projects, contributes to providing regulatory solutions to business requirements and changes to the regulatory landscape
- This position provides operational regulatory input and guidance to cross-funtional teams, ensuring compliance to global regulations.
Main Duties and Responsibilities:
- Responsible for regulatory submission activities and reporting
- To facilitate standards compliance verification activities for specific product families
- Contribute to regulatory intelligence to produce and maintain applicable standards and processes
- Regulatory responsibility for the compliance lifecycle management for assigned products/projects
- To perform regulatory review of business documentation e.g marketing material, design changes
- Liaise with external regulatory bodies and internal business fucctions
Experience and Qualifications Required
- Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
- 3 years regulatory experience gained on Class II Medical Devices
- Experience of ISO 13485
- Knowledge of ISO14971, BS EN 60601, IEC 62366 and IEC 62304
- Proactive and solutions orientated
- Experience with Project Management
- Experienced interaction with regulatory agencies
- Knowledge of risk management and design validation approaches
- Understanding of type testing relating to software medical devices, electrical safety and other directives applicable to software medical devices.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.