Just Recruitment
11 Aug 2017
19 Aug 2017
Contract Type
Full Time
The Just Recruitment are currently recruiting for a Medical Device Quality and Regulatory Consultant (Home based).

Our UK client is actively looking for a Medical Device Quality and Regulatory Consultant - EN 13485, Medical Device Directive and FDA

The role will be supported by a comprehensive office based staff and computerised systems
Clients range from start-ups to multinational organisations. The role is more than a consultant or auditor it is a truly hands on function.

Specialist skills in one or more of the following would be an advantage:
-Sterile Products
-Electronic devices
-Anaesthesia systems

Duties for this role will include :-
-Managing the whole Quality and Regulatory system for clients
-Planning and conducting Medical Device QMS management system audits leading to specific accreditations
-Providing specific technical support to expand the Company's capability to offer valued services to existing and new customers
-Conducting audits on QMS / technical / manufacturing systems and technical/regulatory documentation
-Participate in the interpretation of Regulatory Requirements (ISO13485, Medical Device Directive MDD 93/42/EEC and 21 CFR Part 820) to produce effective working policies and procedures.
-Documenting on behalf of the client Technical Files, Design Dossiers for CE marking and FDA 510(k) applications.
-Representing the customer at Notified Body and FDA audits
-Visiting customer sites, undertaking audits / inspections / developing full documentation and ensuring timely delivery of reports and documents

Working under your own initiative, this role will require someone to manage their own workload, working directly with customers to ensure that audit dates are arranged and deadlines always met

Applications are invited from candidates with a BSc in a scientific subject or equivalent experience, together with proven experience of carrying out Medical Device manufacturing site audits. In addition he / she must have experience gained interacting with a Notified Body or the FDA.

Note : This role can be based from home but will require travel in the midlands and north of England with overnight accommodation typical one or two nights per week. Some opportunities for international travel exist. There will be a requirement to visit the head office based in the south east.

For more information on this position, please contact Just Recruitment Group Ltd, at or telephone 01376 528660 quoting job reference B903119.

Please note that if you have not been contacted within 7 days, your application for this position has been unsuccessful.

Just Recruitment Group Ltd. trading as: Key Personnel, Select Recruitment, are only able to process applications from candidates who are currently resident and eligible to work in the UK.

With over 30 years experience delivering a quality temporary, permanent and contract recruitment service for Office, HR, Industrial, Technical, Engineering, Law and Finance, the Just Recruitment Group works successfully with an extensive list of local businesses, providing an honest, ethical and professional service to both candidates and clients. With branches in Braintree, Ipswich, Haverhill, Sudbury, and Witham we are positioned to offer services with Essex, Suffolk, Cambridge, Norfolk and the Home Counties.

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