RA Officer Medical Device Remote

Job Description

Regulatory Affairs Officer (Medical Device) Remote, £32-40kOur client, a rapidly growing Medical Equipment Manufacturing organisation are looking for a RA Officer to join their team either in Newcastle or on a totally remote basis.Role responsibilities:To cover and maintain the RA system in accordance with the latest relevant standards for the product ranges produced. Assist in registration of devices with worldwide regulatory bodies and collate the necessary information. Manage vigilance reporting aspart of post-market responsibilities.Regulatory Responsibilities:

• Comprehensive understanding of regulatory requirements applicable to the company.
• Working knowledge of 13485 & MDD/MDR & MDSAP and UKCA and any other applicable standards.
• Ensure technical files are maintained and reviewed regularly against all regulatory standards.
• In Q Pulse System ensure all codes are allocated to relevant technical files, obsoleting, and archiving as appropriate.
• Develop and maintain internal Standard Operating Procedures in alignment with global standards.
• Remain informed of global regulatory updates/information.
• Ensure Declarations of Conformity up kept up to date and embedded into Q Pulse System.
• Allocate GMDN code nomenclature and name to all products.
• On MHRA website ensure all information is current and up to date.
• Liaise with the Quality department on aspects of quality related documentation where required.
• Liaise with Authorised Representative to provide notifications to the EU Competent Authority.
• Work to current regulations.
• Work alongside NPD in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas for easy access.
• Update any relevant databases as assigned.
• Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company objectives.
• Ensure naming conventions are consistent throughout all documentation.
• Cover for other areas in the department when required.

Vigilance Responsibilities

• Handling of reportable product non-conformities as defined by country-specific guidelines.
• Implement and maintain established regulatory reporting processes and procedures, including review of complaints within set timescales to determine whether reporting requirements have been met.
• Advise on country requirements with regards to changes in regulatory reporting requirements for medical devices and ensure that the processes are kept up to date.
• Undertake mock FSCAs (recalls) involving distributors, as required.
• Co-ordinate product FSCA (recall) if/when required, working alongside appropriate departments, and communicating with customers to ensure actions are undertaken in a controlled, efficient, and timely manner.
• Ensure SOPs for these areas are correct at all times.

Role requirements:

• Hold a degree in a life science
• Experience of handling sensitive or confidential information E Working knowledge of 13485, 93/42/EEC & 510(k)
• Has an understanding of Regulatory Bodies product and company registration routes/requirements E Effective communication with regulatory authorities

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.