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İstanbul(Avr.)(Bakırköy)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Registration

Registration

Application Count

78 application

Job Type

Full-Time

Position Level

Specialist

Application Count

78 application

Department

Registration

QUALIFICATIONS AND JOB DESCRIPTION

Your work will focus on

  • Regulatory responsibility for the Middle East region, Africa, and non-regulated WHO countries within the Global Life Cycle Management Group of the Regulatory Department. 
  • Preparation and processing of registration documents within the product development regarding international requirements as above definedined regions and in partnership with the executive management. 
  • Maintenance of technical product documentation within the Global Life Cycle Management Group of the Regulatory   Department. 
  • Responsible for national components of approval procedures and projects in coordination with the Global Life Cycle Management team for their regions. Responsible for international approval projects; compiling of all necessary documents for international registrations; change notifications, registrations, and support for the whole process; regular status updates.
  •  Maintenance and updating (changes notifications, renewal) of registrations (life-cycle-management) and assurance of reliable and punctual completion. 
  •  Ensuring of high-quality processing of requests of authorities and compliance of legal requirements in the medical device area. 
  •  Cooperation within the interdisciplinary team for implementation and realization of new regulatory requirements. 
  •  Creation of gap analysis for new regulatory requirements. 
  •  Provision and support of external certification audits. 
  •  Planning, provision, and documentation of internal and supplier audits. 
  •  Coordination of interface between the departments Regulatory Affairs and Development, within the life-cycle- management stages. 
  •  Participation in the interdisciplinary team for planning, contributing, documentation, and coordination, of CAPA, Change Management, and Product Labelling. 
  •  Flexible and open to providing assistance in non-specific daily work tasks when and wherever needed. 
  •  Maintaining the eSENGO database, creating Product Sales Approval, and approving Delivery Notes after investigation. 
  •  Responsible for submission of adverse event reports to MoH in Turkey via UTS (Product tracking system). 
  •  Deputy for the Person Responsible for Regulatory Compliance (PRRC) ensuring compliance with conditions set forth by REGULATION (EU) 2017/745, article 15, 3 (b, c, d, and e) at Occlutech Ltd.
  • Responsible for establishing communication with internal stakeholders, health care providers, and ethical bodies (as applicable), to release medical devices to the market and document this release under the company’s QMS and global “special access” (compassionate use cases) programs for non-approved devices or for unmet needs of approved devices.

We are looking for a candidate, who has

  • Diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
  • Good professional experience in quality management systems.
  • English knowledge CEF (Common European Framework) Level: B2.2

Preferred Candidate

More than 4 years of experience
Bachelor’s(Graduate), Master’s(Graduate)
Completed
Class B

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Hakkımızda

Occlutech the leader in developing innovative products for the treatment of structural heart disease. The Company sells and markets ASD, PFO, PLD and

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Yan Haklar

Özel Sağlık Sigortası, Servis, Yemek Kartı (Setcard, Ticket, Multinet, Sodexo vb.).

Ruhsatlandırma Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Ruhsatlandırma Uzmanı Ruhsatlandırma Uzmanı Maaşları Ruhsatlandırma Uzmanı Nasıl Olunur? Ruhsatlandırma Uzmanı Nedir? Ruhsatlandırma Uzmanı İş İlanları