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Job Details

Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Reference: TD0611
Closing Date: 14 Jan 19
Type: Permanent
Salary (£): On Application

Job Summary:

New opportunity for a Regulatory Specialist to join a Global Medical Device company.   Fantastic new role with scope for autonomy and career progression.


New opportunity for a Regulatory Specialist to join a Global Medical Device company.   Fantastic new role with scope for autonomy and career progression.

This is a role that offers leadership, autonomy and career progression.

Key Responsibilities:
•    You will be responsible for generating and maintaining technical files for CE Marked Products and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply to the company. 
•    FMEA execution and Risk management reports as per ISO 14971 as part of technical file updates. 
•    You will liaise with auditing bodies and regulatory authorities in all relevant matters relating to the company. 
•    You will have responsibility for replying to customer and regulatory queries in relation to quality, technical and regulatory information for products manufactured & distributed by the company. 
•    As part of the QA function you will participate in internal audits.
•    Perform gap analysis to ensure compliance to Guidelines such as EU directives and EU GMP guidelines, Annexes and Company Manufacturing Authorization. 
•    Respond and execute field safety corrective actions when required. 
•    Analyse quality systems and processes for improvement. 
•    Assist in deviations, SCARs, complaints, non-conformances. 
•    Update internal quality documentation. 
•    Liaise with the relevant component authorities and notified bodies of incidents and Field safety corrective action. Execution of field safety corrective actions. 
•    Assist with the overall compliance to the quality system. 

Education & Experience  
3rd level qualification in a Quality or Scientific discipline. 
Industry experience within regulatory affairs / regulations within a medical device company or Pharmaceutical field. 
Experience in Quality Assurance within the medical device or Pharmaceutical industry. 

 For JOB SPEC and full details please send your CV to or call Tina at +353 1 2784671
Log on to for full list of active vacancies.  Thornshaw is a division of the CPL group.

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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