Compliance / Regulatory Assistant (Ft)
1 month ago
**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.
- 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.
**About TRCGroup**:
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