Regulatory Affairs Manager

Gold Group Ltd

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Job ID :

5365


Company Type :

Staffing Firms


Industry :

Manufacturing and Production


Education Level :

Bsc


Address 1 :

United Kingdom,--St.Albans,St. Albans,


Key Skills :

medical device; regulatory; quality;management


Salary :

£55000 - £60000 per annum + bonus + benefits


Date Posted :

06 Dec, 2016



Company Name :

Gold Group Ltd


Location1 :

St. Albans




Job Category :

Medical Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Job Title:Regulatory Affairs & Quality Assurance Manager
Specialist Area: Medical Devices
Location:St Albans
Pay:£55,000 - £60,000 + company bonus + benefits
Job Type:Permanent, Full Time, Office based
Company:Gold Group Ltd - Client to be discussed upon application

Are you an experienced Regulatory Affairs Manager with a strong understanding of Quality Assurance and a background in Medical Devices. This is a newly created position and will report directly in to the Regulatory affairs Director.

This is a very dynamic company specialising in the manufacturing and distributing unique, innovative products within the healthcare industry to Hospitals, Hotels and the travel and leisure industries. It exports its products to over 40 countries worldwide and is expanding further. There will be a chance to travel internationally (10%) to America, Europe and APAC. The position is a full time office based

Key Responsibilities

*Lead a team of Regulatory & Quality Specialists
*The creation, management and maintenance of Technical Files for Class I, IIA and IIB Medical Devices
*Management of ISO 13485 & ISO 9001 Quality Management System
*Efficacy data & Stability data
*Design history and design development
*Conducting external and Internal audits across client sites
*Assistance for other RA Executives - Technical file data for BPR dossiers (Biocidal Procut Regulations)
*Assistance for other RA Executives - Technical file data for Cosmetics Regulations, i.e. PIFs

Qualifications and Experience

*At least 10 years Medical Device experience
*Solid experience within Regulatory affairs
*Line Management Experience
*Experience in Biocides Directive
*Experience of the MDD 93/42/EEC with experience of Technical file building and submissions under this Directive (Essential)
*Understanding of cosmetic / Personal Care regulatory affairs is desirable
*BSc (or equivalent) in Science
*Ability to understand and enable implementation of regulatory standards

How to Apply:

If this sounds like the sort of role for you and you have the relevant experience, please apply for this position quoting reference number 933 410.

However, if this is not the role for you but you are looking for a new career position and you would like to know what other opportunities I have, please email or call me for a confidential conversation on +44 (0) 1342 330 571.

As a final point we will give you £200 if you refer someone and we place them……. so there's never been a better time to recommend a friend or colleague.

Job Title:Regulatory Affairs & Quality Assurance Manager
Specialist Area: Medical Devices
Location:St Albans
Pay:£55,000 - £60,000 + company bonus + benefits
Job Type:Permanent, Full Time, Office based
Company:Gold Group Ltd - Client to be discussed upon application



This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business.

Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.


Company Name:

Gold Group Ltd


Headquarters:

5th Floor East Grinstead House,Wood Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

RH19 1U


Website:

www.goldgroup.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

East Grinstead


Phone No. :

01342 330 500


For more information,visit www.goldgroup.co.uk.

View all Gold Group Ltd Jobs



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