RA/QA Specialist in Leamington Spa

Leamington Spa
26 Nov 2018
24 Dec 2018
Regulatory Affairs
Contract Type
Jenni at CK Group is recruiting for a RA/QA Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Leamington spa on initially a contract basis for 12 months with strong potential to be further extended/made permanent.

Our client is a company that supports healthcare professionals in over 100 countries in an effort to improve the lives of their patients. The company takes a pioneering approach to the design of advanced medical products and services by securing wider access to their diverse technologies for more customers globally and by enabling better outcomes for patients and healthcare systems. They hold leading positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine to name a few.

This role is located in Leamington Spa and easily commutable from Coventry, Rugby, Birmingham and Oxford. Their site is based a short distance from the A46 and is easily accessible for commuters using the M40 or railway.

The Role:
This Regulatory Affairs/Quality Assurance (RAQA) position is responsible for representing the RAQA function for all Field Safety Corrective Actions (FSCA), including reporting related activities to the Competent Authorities. The RA/QA specialist will assist the Group Manager with other RA duties as required which may include dealing with product registrations and managing Certificates of Free Sale (CFS) with the MHRA.

The main purpose of the role will be to:
 - Participate as core member of the Field Action Team.
 - Complete and/or manage Competent Authority reporting activities related to FSN, FSCAs and follow ups, either directly or via local RA personnel.
 - Act as single point of contact with the UK & Ireland Competent Authorities for FSCA and related matters.
 - Collate and report evidence of FSCA closure for each affected country within EUCAN (EU & Canada) region.
 - Direct non-standard questions to the relevant functions/teams.
 - Manage Competent Authority expectations and ensure timeliness of responses related to FSCAs.
 - Develop and assist in product registrations and re-registrations, including the supply of necessary documents for Europe and Canada and to existing approved countries.
- Work with the MHRA in managing and obtaining Free Sales Certificates, legal for Notary signatures and Embassies for legalisation of documents.
 - Assist in the development, review and implementing regional policies and procedures based on corporate and regional requirements.      
 - Assist in regulatory aspects of commercial business relationships to ensure compliance.  
 - Assess commercial activities in the EU for RAQA compliance and propose and implement potential solutions.

Your Background:
To be considered for this role, you should have the following skills, knowledge and experience:
 - Prior experience in regulatory affairs and/ or quality assurance with degree or similar level qualification in a technical field.
 - Excellent English, both written and verbal.
 - Proficient in Word and Excel, and good writing skill is needed.
 - Ideally have experience in MS Access, MS Visio, Agile, and SAP.

Working Hours for this role are: Mon to Thur 8am - 4.30pm - Fri 8am to 1.30pm.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44035 in all correspondence.

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