Regulatory Affairs & Quality Assurance Officer - Canon Medical

The Regulatory Affairs & QA Officer is responsible for the administration and maintenance of the Quality, Environmental and Health & Safety Management Systems.

REPORTS TO:

Regulatory Affairs and QA Manager

RESPONSIBILITIES:

QA Management

1. Manage the electronic Document Management system, produce documentation such as SOP’s, WI’s, Doc’s etc. Liaise with QA Consultant on the same. (includes work on ISO14001, OHSAS18001 and ISO27001 systems)

2. Perform and manage internal QA audits if and when required. Maintain audit records as well as CAPA.

3. Manage/approve product records in the Product Registration Database (PRS)

4. Manage, monitor and progress complaints. Liaise with Service Dept, BU and various TMSE counterparts to effect progress.

5. Escalate ‘hot’ complaints to the Manager Regulatory Affairs and QA

6. Assist with carrying out risk assessments on new business processes and ventures using Quality techniques such as FMEA, Fishbone diagrams, Cause and Effect matrices, Pareto charts

7. Perform Root Cause analysis using suitable techniques – carry out training to staff

Regulatory Affairs

1. Assist with running the various compliance schemes (Anti-Bribery, EU Competition Law, Data Protection etc)

a. Provide employee introductions for the various schemes

b. Prepare e-training assignments, monitor completion and chase.

2. Assist with implementation of corporate programs as under 1).

3. Ensure training records are maintained

4. Prepare annual reports for the above together with the Manager Regulatory Affairs and QA

5. Responsible for annual and quarterly submissions of WEEE and Battery Data to Environment Agency/Compliance Scheme(s). Liaise with TMSE on the above.

6. Respond to QA and RA queries in commercial tenders and questionnaires in a timely manner.

EXPERIENCE/QUALIFICATIONS REQUIRED:

· Good general standard of education, with excellent written and spoken English, preferably to degree level.

· A working knowledge of the various standards

· Certified as an internal auditor for ISO9001 and ISO13485

· A technical background is desirable to allow ready understanding of engineering principles and working practices.

· Ability to train/instruct people either one to one or class room based

· Good Numeracy

· Excellent MS Excel skills

· Prepared to travel occasionally to various location within the UK, as well as abroad