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October 23 2018

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Regulatory Affairs manager:Fastnet ? The Talent Group

Job description:

Regulatory Affairs manager

Fastnet - The Talent Group

   » Wexford
   » Negotiable
   » Permanent full-time
   » Updated 12/10/2018
   » Claire McGuckin this job is expired SaveSave Apply Now

Job detail

Permanent Regulatory Affairs Specialist function for Leading Wexford located Medical Device Client

The Regulatory Affairs manager will be responsible for the development, maintenance, and distribution of quality documents within the QMS ensuring compliance to significant regulations, applying expertise in the discipline of document management for the analysis and resolution of document management issues, including benchmarking against best practice and implementing innovative solutions.

   » Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System - Management of the PMR system,Change Control Process and Documentation Control system for the QMS.
   » Ensuring continuous compliance with the following: FDA Quality System Regulation 21 CFR 820 (QSR), Medical Device Directive, Health Canada Medical Device Regulations, ISO13485 Medical Device Quality Management System, ISO14971
   » Provide advice on regulatory affairs requirements for all proposed changes to device design.
   » Compilation of regulatory submissions: PMAs, CE Mark registration, 510(k) registration, Technical Dossiers and similar applications and notifications, annual reports, supplements and registrations.
   » Leading the preparation and direct all activities for: FDA inspections, ISO 13485 surveillance audits, Corporate audits, Internal audits and Customer audits
   » Customer complaint investigation, reporting, closure and trending.
   » Review current technical product files for compliance to international requirements.
   » Answer all customer regulatory requests and complaints.
   » Act as regulatory affairs representative on product design and R&D redevelopment teams.
   » Design and implementing quality systems improvements.
   » Support plant validation documentation programs as required, ensuring records are maintained.
   » Degree or equivalent combination of education and practice
   » 3+ years configuration management/document control practice.
   » 3+ years of prior managery or management practice.
   » Competent in preparing written communication and correspondence.

Fastnet has a strict confidentiality policy - please be assured that your details will never be mailed to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists
Ref: JO-1705-62518_1538048358
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Fastnet - The Talent Group


   » Eastgate Village, Eastgate Business Park, Little Island, Cork
   » 021 4509200


Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Wexford
Company Type Employer
Post Date: 10/12/2018 / Viewed 3 times
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Company: Fastnet ? The Talent Group
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