COMPLIANCE / REGULATORY ASSISTANT

37.5 hours per week Monday-Friday

£20,000 - £25,000 dependant on experience

Halifax

**Temp maternity cover with a minimum of 12 months, with the opportunity to be kept on permanently due to current growth plans**

TRC are working with a company who are specialists in medical equipment development and distribute these products Worldwide. An organically grown company founded over 25 years ago with growth plans in place.

The Candidate

* A strong understanding and proven experience of ISO 9001 Quality Management and regulatory bodies processes in a similar role.

* Knowledge and proven experience with Medical Devices and EN standards field

* Great organizational and time management skills.

* Be confident on Microsoft packages, particularly Word and Excel spreadsheets.

* You must have the initiative and the ability to work on your own, be flexible and adaptable with the ability to multitask and remain calm under pressure.

Responsibilities

* Support and co-ordinate in re-certification of the companies ISO 9001 Quality Management and 14001 Environmental policies annual inspections

* Ensuring all appropriate standards and regulatory technical files for new and existing products are updated in line with the MHRA, FDA and specific countries regulations.

* Review and compile Compliance documentation and report against relevant standards for compliance - highlight non-conformities.

* Planning and conducting audits of medical devices

* Support in the running of the Health and Safety, HR policies and Audits

* Updating company supplier Agreements and distributors Contracts

Skills and Requirements

* Experience of working with quality and regulatory standards including ISO 9001

* 2 years' experience in Regulatory affairs within the medical devices industry

* Previous experience working in a Compliance role.

* Formal qualifications will be looked on favourably.

* Competent on Microsoft packages, especially Excel which is essential.

* Computer literate with good literacy and numeracy skills.

On offer to the successful candidate is an attractive basic salary and benefits, giving you the ability to work with a dynamic, fast-growing company where the career opportunities are inexhaustible