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Job Details

Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location: Limerick
Reference: DB9659
Closing Date: 18 May 18
Type: Maternity Cover
Salary (£): On Application
Benefits:

Job Summary:

Regulatory Affairs Specialist required for global medical device company!

Requirements:

This is a maternity cover role.  The successful candidate will report to the Regulatory Affairs Manager and will have responsibility for the following:


•    Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
•    Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. 
•    Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
•    Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
•    Provides support to currently marketed products as necessary including input on change requests, etc.

Applications are invited from Candidates with the following background and experience:

•    Third level Qualification in Science/Engineering, at least 5 years experience in a regulated industry in a similar role.
•     Thorough knowledge of the EU, MDD requirements.
•    Knowledge of requirements in GHTF countries.
•    Desirable to have knowledge of requirements in other jurisdictions.
•    Knowledge of medical device quality standards/practises or similar regulated industry
•    Good communication and inter-personal skills.
•    Proven problem-solving skills.
•    Good computer skills including knowledge of Microsoft® Office.
•    Proven organisational skills.
•    High self-motivation.
•    Approved External Auditor.
•    Willingness to travel on company business

For a full Job Spec and to apply for this position please call Deirdre at +353 1 2784671 or  email your CV in the strictest confidence to   dbolger@thornshaw.com

 

Apply for this job: 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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