Loc de munca Quality Assurance and Regulatory Affairs Specialist
Companie Medicala
Pozitie :Quality Assurance and Regulatory Affairs Specialist
Tara : Republica Irlanda
Locatie : Dublin
Pozitii disponibile: 1
Locul de munca: Companie privata
Salariu : se negociaza la interviu
Ce ofera Angajatorul :
• Perioada contractului: nedeterminata
• Asigurari sociale,
• Asigurari medicale,
• Ore suplimentare ,
• Concediu platit,
• Bonusuri- prime de concediu,
Conditii de recrutare:
As a member of the Quality Systems Team the QA/RA Specialist is responsible for ensuring continuous compliance with the following:
• FDA Quality System Regulation 21 CFR 820 (QSR)
• In Vitro Diagnostic Medical Device Directive 98/79/EC
• Health Canada Medical Device Regulations
• ISO13485 Medical Device Quality Management System
• Assisting QS Manager with the Maintenance of the Quality Management System
• Advising on regulatory affairs requirements for all proposed changes to Operations.
• Compiling of regulatory submissions: annual reports, supplements and registrations.
• Act as regulatory affairs representative on product design and R&D redevelopment teams.
• Support R&D in preparation of DHFs and Technical Files to ensure products meet regulatory requirements
• Team lead in preparation activities for FDA inspections, customer audits and ISO 13485 surveillance audits and follow through on close out of any subsequent actions assigned.
• Reviewing customer complaints, CAPA’s and Change Controls
• Reviewing current technical product files for compliance to international requirements.
• Maintaining and developing CAPA and associated trends
• Performing internal quality audits and supplier audits as required.
• Designing and implementing quality systems improvements.
• Global registrations for all labelled products
• QA & RA activities for Ireland – Norwegian Branch & UK Branch
• Global regulatory support for all labelled products
• Any other duties as required
• Life Science degree or equivalent
• Qualification in Quality Assurance or Regulatory affairs is desirable but not essential
• 3 years + experience in a quality or regulatory role in the pharmaceutical, healthcare or medical device/IVD sector essential, preferably in an FDA regulated environment
• Knowledge of quality management systems and current International and European regulations/ standards with respect and in vitro diagnostics/ medical devices
• Excellent attention to detail and organization skills.
• Good problem solving and decision making
• Ability to work on own initiative and as part of a team
• Excellent interpersonal skills
• Excellent verbal and written communication skills (articulate and clear).
• Advanced PC skills for Excel and Word.
• Experience with USA regulatory requirements.
• Ability to work under pressure and meet tight deadlines.
Ce trebuie sa faceti???
Pasul 1: Ne trimiteti cv-ul in limba engleza completat, si o poza cu dvs.
Tara : Republica Irlanda
Locatie : Dublin
Pozitii disponibile: 1
Locul de munca: Companie privata
Salariu : se negociaza la interviu
Ce ofera Angajatorul :
• Perioada contractului: nedeterminata
• Asigurari sociale,
• Asigurari medicale,
• Ore suplimentare ,
• Concediu platit,
• Bonusuri- prime de concediu,
Conditii de recrutare:
As a member of the Quality Systems Team the QA/RA Specialist is responsible for ensuring continuous compliance with the following:
• FDA Quality System Regulation 21 CFR 820 (QSR)
• In Vitro Diagnostic Medical Device Directive 98/79/EC
• Health Canada Medical Device Regulations
• ISO13485 Medical Device Quality Management System
• Assisting QS Manager with the Maintenance of the Quality Management System
• Advising on regulatory affairs requirements for all proposed changes to Operations.
• Compiling of regulatory submissions: annual reports, supplements and registrations.
• Act as regulatory affairs representative on product design and R&D redevelopment teams.
• Support R&D in preparation of DHFs and Technical Files to ensure products meet regulatory requirements
• Team lead in preparation activities for FDA inspections, customer audits and ISO 13485 surveillance audits and follow through on close out of any subsequent actions assigned.
• Reviewing customer complaints, CAPA’s and Change Controls
• Reviewing current technical product files for compliance to international requirements.
• Maintaining and developing CAPA and associated trends
• Performing internal quality audits and supplier audits as required.
• Designing and implementing quality systems improvements.
• Global registrations for all labelled products
• QA & RA activities for Ireland – Norwegian Branch & UK Branch
• Global regulatory support for all labelled products
• Any other duties as required
• Life Science degree or equivalent
• Qualification in Quality Assurance or Regulatory affairs is desirable but not essential
• 3 years + experience in a quality or regulatory role in the pharmaceutical, healthcare or medical device/IVD sector essential, preferably in an FDA regulated environment
• Knowledge of quality management systems and current International and European regulations/ standards with respect and in vitro diagnostics/ medical devices
• Excellent attention to detail and organization skills.
• Good problem solving and decision making
• Ability to work on own initiative and as part of a team
• Excellent interpersonal skills
• Excellent verbal and written communication skills (articulate and clear).
• Advanced PC skills for Excel and Word.
• Experience with USA regulatory requirements.
• Ability to work under pressure and meet tight deadlines.
Ce trebuie sa faceti???
Pasul 1: Ne trimiteti cv-ul in limba engleza completat, si o poza cu dvs.
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