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Job Details

Senior Regulatory Affairs Associate

Company: JCW Life Sciences
Location:
Reference: JCW Senior RA
Closing Date: 09 Feb 17
Type: Full Time
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

I am currently recruiting on behalf of a leading global Medical Device company based in Oxfordshire. They are looking to hire an experienced Senior Regulatory Associate to join the company to help lead regulatory functions in the business for registration projects.

Requirements:

Senior Regulatory Associate – Medical Devices

 

Oxfordshire

 

£30,000 - £35,000

 

I am currently recruiting on behalf of a leading global Medical Device company based in Oxfordshire. They are looking to hire an experienced Senior Regulatory Associate to join the company to help lead regulatory functions in the business for registration projects.   

 

Role and Responsibilities:

Reporting duties to Director QARA
Identify and implement continuous process improvement projects, methodologies and tools to effect efficiency change and associated cost reductions / lean.
Ensure compliance to all processes related to the requirements of Regulatory Affairs Dept.
As voice of the Customer; ensure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality Policy.

 

Skills and Expertise:

·      Review and approve labelling, marketing literature and claims substantiation compliance.

·      Working closely with the New Product Introduction and R&D team to lead regulatory input in R&D project with project management and team members

·      Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.)

·      To maintain an awareness of the company's external regulatory contacts and define sources of information appropriate for performing key tasks.

·      Maintenance of site establishment registrations and device listings & maintain regulatory database

 

If this sounds of interest, please get in touch for more details and a further discussion.

If this is not for you, but you know someone who may be interested, please feel free to forward my details on to them for me to get in touch. We offer £250 holiday vouchers for successful placements as a result of a referral.

 

QA / QUALITY ASSURANCE / 13485 / AUDITING / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / VASCULAR / WOUNDCARE / WOUND CARE / QUALITY MANAGEMENT / QUALITY SYSTEMS / PRODUCTION / HEALTHCARE / QA ASSOCIATE / SENIOR QA ENGINEER / MEDICAL DEVICES / ISO 13485 / ISO 9001 / CAPA / COMPLIANCE / COMPLIANCE ENGINEER / DOCUMENTATION / FDA / EUROPEAN / REGULATORY AFFAIRS / REGULATORY SPECIALIST / REGULATORY ENGINEER / RA SPECIALIST / REGULATORY AFFAIRS / VIGILANCE / REGULATORY SUBMISSIONS / MHRA / QMS / REGULATORY COMPLIANCE / REGULATORY CONFORMANCE / 60601 / 60602 / FDA / CFR 21 / RA OFFICER / RA EXECUTIVE / REGULATORY AFFAIRS

Apply for this job: Senior Regulatory Affairs Associate

Contact Information:

Address:  Head Office
27-32 Old Jewry
London
EC2R 8DQ
England
Tel:  +44 (0) 203 589 9300
Fax:  +44 (0) 203 006 8808
Website:  Visit Our Web Site

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