Quality Assurance / Regulatory Affairs Manager

Tonbridge, Kent
Great + Benefits
15 Feb 2021
15 Mar 2021
David Cotton
Job Level
Contract Type
Full Time
Quality Assurance / Regulatory Affairs Manager
Location - rural Tonbridge
Salary - £Neg + Bens

Working for a leading manufacturer with a long track record of success this is a great opportunity to use your experience as they continue on their upward trajectory.
In summary, the role will see you organising and planning all Regulatory Affairs and Quality Management functions including product registration, complaint handling & reporting, and audits.

You will also serve as the Quality System Management Representative and Medical Device person responsible for Regulatory Affairs covering the latest editions of ISO13485, FDA CGMP QSR and MHLW Ministerial Ordinance No. 169 plus any other relevant regulatory quality standards), reporting on its performance to top management for review and as a basis for continual improvement.

Required Qualifications

Degree educated or equivalent, in a life science or engineering discipline

A minimum of 5 years' experience in a medical device regulatory environment

In-depth knowledge and appreciation of the regulatory requirements including technical files for placing class I & II medical devices on the European market. Experience in other markets (North America, Asia-Pacific markets) would be desirable.

Strong Knowledge of the Medical Device Directive (MDD) and Medical Device Regulations (MDR)

Experience in dealing with Notified bodies or competent authorities.

Strong leadership and influencing skills

Experience building a high performing team, managing the performance of team members with varying levels of skill and experience

Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales.

Excellent verbal and written communication skills, including great attention to detail, strong questioning & listening skills and problem-solving abilities.

Strong knowledge of MS Office and databases

Analytical and statistical techniques required along with proficiency in Word and Excel

At KHR we take care to ensure that you are represented as well as possible so it is worth checking your CV for layout, spelling and grammar as well as making sure it is up to date before you submit. If you feel you need to highlight particular qualifications, skills or relevant experience with regards to a specific role then please add a cover letter or a preface page. This does not need to be formatted in the same manner. In addition, if your CV is heavy with graphics etc, please could you also submit a "clean" copy in Word. Thank you.

KH Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. KHR - Recruitment Specialists is a trading name of KH Recruitment Ltd Keep in touch with us online for job alerts, industry updates and market...

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