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Job Details

Regulatory Affairs Specialist

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

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.

Requirements:

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 tdunne@thornshaw.com or call Tina at +353 1 2784671
Log on to www.thornshaw.com 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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