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Regulatory Affairs Officer - Home Working


Tyne and Wear







Company Description

Our client are specialists in their market sector, they are looking for a skilled Regulatory Affairs Regulatory Officer to join their team on a permanent basis.

Job Specification

The Job you’ll do

  • 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 clients Authorised Representative to provide notifications to the EU Competent Authority.
  • 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.
  • 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.
  • Assist in client meeting it’s regulatory reporting obligations – when applicable – by liaising with relevant bodies and working with colleagues to progress the investigation and to keep all informed and updated as required.
  • Advise on country requirements with regards to changes in regulatory reporting requirements for client devices and ensure that the client 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 SOP’s for these areas are correct at all times.

About You

  • Undertake training and development as required.
  • Knowledge of 13485 & MDD/MDR & MDSAP and UKCA and any other applicable standards
  • Self-Reliance with the ability to work with the minimum of supervision, on his/her own initiative.
  • The job entails interaction between departments within client 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.


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