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Job Details

Regulatory Affairs Specialist, Medical Devices

Company: Key People Limited
Location: Hertfordshire
Reference: BBBH23124
Closing Date: 29 May 18
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

An excellent opportunity has arisen for a Regulatory Specialist to join a leading global Medical Device company based in Hertfordshire. If you have a background within Regulatory Medical Devices, and are keen to gain Class III product exposure, this role will offer you excellent career progression.

Requirements:

An excellent opportunity has arisen for a Regulatory Specialist to join a leading global Medical Device company based in Hertfordshire. If you have a background within Regulatory Medical Devices, and are keen to gain Class III product exposure, this role will offer you excellent career progression.

MAIN RESPONSIBILITIES:

Product Field Safety Corrective Actions (FSCA) in the region, including sign-off, and their efficient and timely execution, including to plan closure as per EMEA region and Corporate plans
Post Market Surveillance (PMS) activities in the region to enable the EMEA RA and Quality operations to meet their reporting obligations to Regulatory Agencies
Be, as necessary, a point of contact for the UK and Ireland Regulatory Agencies in respect to FSCA’s, Vigilance and Post Market Surveillance issues
Regulatory and Quality compliance for the region through appropriate documentation and filing in respect to RA and Quality regional activities (egs FSCA’s, Vigilance and PMS)
If necessary, escalate RA and Quality issues to senior management level ensuring awareness
Correspond and liaise with Regulatory and Quality contacts in EMEA region and Corporate, to act pro-actively to ensure Regulatory requirements for the region are met efficiently
As appropriate, participate in RA and Quality projects/working parties with EMEA region and/or Corporate groups
As necessary develop and execute local RA initiatives/activities in line with Corporate and EMEA region and Quality requirements.
As required provide RA activity reports to senior Management
Advise the regions business and functional units on Regulatory Affairs issues as necessary
As required, manage other, non-product Regulatory requirements related to the region (egs Packaging Waste and WEEE)
Provide training and education on Regulatory Affairs topics both internally and externally as required
Country and European Regulatory knowledge is maintained and developed through own initiatives and Trade Association and Industry meetings/conferences
Complete training in accordance with company procedures and policies
Comply with Business Conduct Standards and anti-corruption policies

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

Apply for this job: Regulatory Affairs Specialist, Medical Devices

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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