Regulatory Affairs Officer
£30000 - £40000 per annum + pension, flexi-time,
Our client, an established Medical Equipment Manufacturer, are looking to appoint an experienced Regulatory Affairs Officer.
The purpose of the role is to cover and maintain the RA/QA 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.
- Comprehensive understanding of regulatory requirements applicable to the company.
- Working knowledge of 13485 & 93/42/EEC.
- Collate product information and keep updated for product ranges to enable use in export registration requests. Drafting a marketing authorisation application.
- 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.
- Ensure Declarations of Conformity up kept up to date and embed 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.
- Ensure all licensing information is logged into Q Pulse system.
- Logging of sterilisation information on the Syspro System.
- Liaise with the Quality department on aspects of quality related documentation where required.
- Work to current MDR.
- Familiarisation with worldwide regulatory bodies and registration requirements.
- 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.
- 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.
- In line with MDR ensure DMR are raised for all product codes and reviewed regularly.
- Undertake training and development as required.
- Self-Reliance with the ability to work with the minimum of supervision, on his/her own initiative.
- The job entails interaction between departments within the Company and with suppliers; it is essential that the jobholder has good interpersonal and communication skills.
- It is essential that the jobholder exhibits a high level of conscientiousness and accuracy in all tasks or duties.
- Pleasant and well presented.
- Have a good telephone manner
- Good organisation skills and methodical approach to work
- The jobholder must maintain and uphold the company values
Hours Of Work
Mon – Thursday inclusive 9am – 5pm Fri 9am – 4pm / Flexi time
Job Reference: AH/RA_1582275876
Salary: £30000 - £40000 per annum + pension, flexi-time,
Salary per: Annum
Baltic Recruitment Sector: Engineering_technical