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Job Details

Quality & Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: TD9163
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Our client, a global medical device company is actively recruiting for a number of QA/RA Specialists. Fantastic opportunity to develop your career within a global organisation.

Requirements:

Our client, a global medical device company is actively recruiting for a  number of QA/RA Specialists.  Fantastic opportunity to develop your career within a global organisation.

Job Purpose

Supporting Post Market Surveillance Activities (Complaints, Reporting and/or Field Actions (FCA) as applicable).  You will be responsible for providing regular status reports to Management and Regulatory Authorities as required.

 

The Role

•             Under limited supervision log and draft responses to specific Field Action queries from Authorities

•             Attend/facilitate meetings regarding Event Investigations and Field Actions

•             Ensuring appropriate recall activities are documented, approved and communicated to relevant parties

•             Preparation and obtaining approval of Field Safety Notices, Field Safety Corrective Action Forms in conjunction with Authorities along with Management

•             Coordination of the issue of the Field Notice and reconciliation of Acknowledgement status from consignees

 

Key Responsibilities

Key responsibilities will include (but are not limited to) the following:

•             Provide administrative support to FCA/EIF specialist, engineers and management

•             Build, develop, and grow business relationships vital to the success of this role

•             Coordinate and minute FCA/EIF meetings

•             Provide support and assistance to FCA/EIF specialist, engineers and management as required on various projects

•             Database management/population

 

Education/ Qualifications:

•             A Degree in a Business/Project Management/Communications or related field  desirable

•             Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment preferable

•             Extensive capability in Microsoft Office

•             Must be fluent in English (Native or bilingual proficiency)

 

•             A friendly enthusiastic, professional

•             Excellent interpersonal skills and the ability to communicate with employees of all levels

•             Flexible and adaptable work ethic

•             Able to work on own initiative and as a team player

•             Good organisational skills with cultural awareness and sensitivity

•             Good judgment and problem solving ability

•             Strong communicator with excellent relationship building skills

 

For further detail please contact Tina at +353 1 2784671 or email in confidence to tdunne@thornshaw.com.  For a list of all vacancies visit our website www.thornshaw.com

Apply for this job: Quality & Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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