Selva Hizmetli

Angestellt, RA&QA Director, Redent Nova GmbH & Co. KG

Berlin, Deutschland

Über mich

Passionate Regulatory Affairs Professional with 13+ years of international workingexperience managing and on-time filing of high-quality regulatory submissions (new drugs,generics, biosimilars and medical devices) interacting with regulatory agency and projectteams in relation to submissions to ensure that all requirements are met. Currently employed as RA&QA Director at Redent Nova GmbH & Co. KG, Germany.

Fähigkeiten und Kenntnisse

FDA
GMP
Technische Dokumentation
Qualitätsmanagement
CAPA
Audit
Lifecycle Management
ISO 13485
ISO
MDSD
Englische Sprache
Qualitätsprüfung
Qualitätskontrolle
Regulatory Affairs
MDR
Medical Devices
Generic drug
biosimilars
new drugs
EMEA
variations
CMC
Life Cycle Management
Class IIa
Clas I
Clas III
artwork
Labelling
PSUR
CCSI
renewal
Submission
manage
authore
Planning
Preparation
on time
Highly motivated
Strong communication & coordination
Agile mindset
Problem Solving
Stress & time management

Werdegang

Berufserfahrung von Selva Hizmetli

  • Bis heute 11 Monate, seit Aug. 2023

    RA&QA Director

    Redent Nova GmbH & Co. KG

  • 8 Jahre und 6 Monate, Feb. 2015 - Juli 2023

    Senior Regulatory Affairs Specialist

    Teva Pharmaceuticals

    Regulatory Affairs

  • 5 Monate, Aug. 2014 - Dez. 2014

    Regulatory Affairs Specialist

    Medist Group Ltd. Co.

    Regulatory Affairs

  • 8 Monate, Dez. 2013 - Juli 2014

    Regulatory Affairs Specialist

    BUSESA Medical Devices Ltd. Co.

    Regulatory Affairs

  • 1 Jahr und 7 Monate, Apr. 2012 - Okt. 2013

    Regulatory Affairs Specialist

    IDE Information Consultancy Education Ltd. Co.

    Regulatory Affairs

  • 10 Monate, Apr. 2011 - Jan. 2012

    Research and Development Project Staff

    European Commission Cordis Funded under 7th FWP

    Research and Project

  • 1 Jahr und 1 Monat, März 2010 - März 2011

    Project Scholar (ARGE Project Worker)

    TÜBİTAK Short-Term R&D Funding Programme

    Research and Project

Sprachen

  • Englisch

    Fließend

  • Türkisch

    Muttersprache

  • Niederländisch

    Grundlagen

Interessen

Social engagement
Cooking
Walking
Travelling
Content Writing

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