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Regulatory Affairs Officer

Industry

Reference

AH/RA_1582275876

Salary

£30000 - £40000 per annum + pension, flexi-time,

Benefits

pension, flexi-time,

Job Type

Job Location

Description

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.

Key Responsibilities/Accountabilities

Regulatory Responsibilities:

  • 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.

Key attributes:

  • 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

Job Duration:

Baltic Recruitment Sector: Engineering_technical

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