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Job Details

Regulatory Affairs Director

Company: Thornshaw Recruitment
Location: Limerick
Reference: DB10003
Closing Date: 14 Jan 19
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

On behalf of my client, a  global medical devices company , I am recruiting for a Regulatory Affairs Director to join their Irish operation.

Requirements:


 In this role you  will be responsible for the Company regulatory strategy and systems for Ireland , and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable.  You will also be  responsible for working with sister manufacturers, to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements. The Regulatory Affairs Director is a member of the  senior management team and the global Regulatory Affairs leadership. 

Candidates with the following background and experience are invited to apply for this role:
•    Bachelor's degree in life sciences or chemistry. An advanced life science degree (e.g. MS, PhD) is preferred.
•    Minimum of 10 years’ experience in medical device regulatory affairs.
•    Solid working knowledge of European regulatory environment.
•    Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills; highly organised.
•    Proven ability to interact in a group environment, have strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders.
•    Thorough understanding of GLP, GCP, GMP, FDA and ICH guidelines.
•    Excellent written and oral communication skills; a detail-oriented work style and the ability to handle multiple tasks.  
•    Must be able to work under pressure and meet deadlines.  
•    Ability to present facts and recommendations effectively in oral and written form.
•    Proficient use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
•    Must be a strategic team builder with good business acumen, combined with hands-on approach.  
•    Excellent communication skills and the ability to interact effectively with all levels of the organisation.
•    Willingness and availability to travel on company business.

For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. 
Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

Apply for this job: Regulatory Affairs Director

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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