Buket M.

Regulatory Affairs & Quality Manager / Person Responsible for Regulatory Compliance (PRRC) at Alsanza GmbH
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Istanbul, Istanbul, Turkey, TR
Languages
  • English-European Language Portfolio(ELP) Code: 9012211464-C2 Level Full professional proficiency

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

5.0

/5.0
/ Based on 2 ratings
  • (2)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

İrma K.

I had the chance to work with dear Buket at Alcon. She has deep knowledge and experience in the field of Pharmaceutical and Medical Device Regulatory Affairs Management. She knows the compliance requirements very well and follows the changes closely. As a Subject Matter Expert, she inspires her colleagues. Buket always communicates effectively and positively, and manages her stress and time very well.

Rekha Roveri

Buket’ support throughout the integration phase was crucial! She is a great team player, always available, well organized, prepared and knowledgeable ...and so capable of communicating with a multicultural environment! Happy to work with you

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Buharlı Sterilizasyon Validasyonu ve Otoklav Validasyonu / Steam Sterilization Validation and Autoclave Validation
    Conswell
    Apr, 2023
    - Oct, 2024
  • Etilen Oksit Sterilizasyon Prosesi ve Sterilizasyon Validasyonu / Ethylene Oxide Sterilization Process and Sterilization Validation
    Conswell
    Apr, 2023
    - Oct, 2024
  • ISO 14971 Risk Yönetimi Eğitimi / ISO 14971 Risk Management Training
    MEDCER ULUSLARARASI MEDİKAL BELGELENDİRME A.Ş.
    Apr, 2023
    - Oct, 2024
  • Radyasyon Sterilizasyonu Doz Belirleme ve Doz Denetimi ve Temel Mikrobiyolojik Testler (Sterilite ve Bioburden) / Radiation Sterilization Dose Determination and Dose Control and Basic Microbiological Tests (Sterility and Bioburden)
    Conswell
    Apr, 2023
    - Oct, 2024
  • FDA Clinical Investigator Training Course
    FDA CDER Small Business and Industry Assistance (SBIA)
    Dec, 2022
    - Oct, 2024
  • Clinical Investigation for Medical Devices and 2017/745 MDR
    AdviQual
    Nov, 2022
    - Oct, 2024
  • EU 2017/745 MDR Technical File Preparation
    AdviQual
    Oct, 2022
    - Oct, 2024
  • EU 2017/745 MDR Vigilance
    AdviQual
    Mar, 2022
    - Oct, 2024
  • CQI and IRCA Certified ISO 9001:2015 Lead Auditor Training Course (Course number 17955 certified by CQI and IRCA)
    BSI Training Academy
    Apr, 2023
    - Oct, 2024

Experience

  • Alsanza GmbH
    • Germany
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs & Quality Manager / Person Responsible for Regulatory Compliance (PRRC)
      • Apr 2023 - Present

      •Stay updated on all relevant regulatory changes, guidelines, and standards related to the company's products and industry. •Develop and implement strategies to ensure the company's compliance with local, regional, and international regulations. •Serve as the primary point of contact with regulatory agencies/NBs and respond to inquiries and requests for information to obtain registration approvals/CE certificates. •Act as PRRC •Prepare & submit regulatory documents and applications to regulatory authorities and NBs as required for product approvals, registrations, and certifications •Ensure that the packaging materials are updated in accordance with the standards •Responsible for world wide regulatory submissions of Class IIa-IIb-III implantable MDs. Preparing the technical files for the targeted countries. •Conduct the product change management. Perform the correspondence with the NB, to submit the changes to the NB for approval •Monitor & track the status of regulatory submissions and approvals, ensuring timely completion •Establish and maintain an effective QMS that aligns with applicable regulations and industry standards (e.g., ISO 13485:2016 etc.). Ensure the QMS sustainity •Conduct/Support internal&external audits to identify areas for improvement and implement corrective actions to address any quality issues •Perform the Complaint Management Process. Take the necessary measures to ensure that the problems encountered are resolved and to prevent their recurrence. Prepare & submit required reports, including AEs reports, to relevant authorities. •Implement risk assessment methodologies to identify and mitigate potential risks associated with product development, manufacturing, and distribution. •Conduct training sessions to educate employees about regulatory compliance and quality management procedures. •Collaborate with external partners, suppliers, and regulatory consultants to facilitate the regulatory approval process and resolve compliance-related issues. Show less

  • VSY Biotechnology
    • Germany
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • MDR Compliance Manager
      • Apr 2022 - Jun 2023

      -Developing and implementing regulatory compliance strategies and procedures for the launch of new devices and the maintenance of existing devices (legacy devices). -Provide compliance program management for safety reporting in accordance with international reporting regulations, Standard Practice Procedures (SOPs) and safety handling guidelines. -Collaborating effectively with Operating Companies and Regulatory, Clinical Research, Medical, R&D, Marketing teams to ensure that applicable regulatory compliance policies and procedures are followed and understood, and that all clinical activities are in compliance with relevant safety reporting procedures, guidelines and processes. -Provide input about worldwide regulatory compliance requirements and standards to relevant departments at the company. -To implement and maintain workflow tools that drive a regulatory monitoring strategy, to compile and evaluate data and information, and maintain a library of indexed, dated and cross-referenced guides for ease of access and reporting. -Performing GAP analysis of the current CERs for the legacy devices and writing MDR compliant CERs for providing the Clinical Evaluation parts of the Product Technical Files. Tracking update periods for CER submissions of the devices. -Creating Methodology for Systematic Literature Review. Supporting the Literature Review and PMCF Plan/Report processes which will be included in CER as the clinical data. Show less

  • Stryker
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Lead Regulatory Affairs and Quality Assurance Specialist, Turkey & CEE
      • Jul 2021 - Mar 2022

      - Responsible for leading all registration related activities and projects for all medical devices portfolio and providing full regulatory support across the related countries (Turkey, Greece and Czech Republic). - Coordinate communication among central RA, local Marketing, CEE country Dealers and Health Authorities. - Contributing on regulatory requirements (preparations, submissions, maintenance of New Products etc.) and in defining the priorities in day-to-day working activities to ensure regulatory compliance and accuracy for the countries of responsibility via using Regulatory field related data tools & softwares/apps. - Responsible for organizing, establishing and maintaining Product Information System and Document Archiving System. Also Preparing and Updating a “Registered Product Information List”. - Follow-up of local regulation updates for medical device products. - Communicate with local authorities and ensure company policies strictly adhere to statutory requirements. - Performing RA Hold management on product orders. - Coordinating and Following up Supplemental Labelling Processes for the countries under responsibility. - Following up the MDR harmonization processes and proactively plan & organize MDR implementations based on global transitions. Show less

  • Medtronic
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Regulatory Affairs Specialist
      • Apr 2016 - Jun 2021

      - Responsible for leading all registration related activities and projects for defined therapeutic areas of responsibility and providing full regulatory support across the related BUs. - Coordinate communication among global RA, local Marketing and Health Authorities. - Responsible for leading the coordination of Field Actions, Recalls/Holds and Vigilance Reports. - Contributing on regulatory requirements (preparations, submissions, maintenance of New Products etc.) and in defining the priorities in day-to-day working activities to ensure regulatory compliance and accuracy. - Responsible for organizing, establishing and maintaining Product Information System and Document Archiving System. Also Preparing and Updating a “Registered Product Information List”. - Follow-up of local regulation updates for medical device products. - Communicate with local authorities and ensure company policies strictly adhere to statutory requirements. - Supporting DCM related to Distributor Applications - Performing DMO requirements for the compliance of Tender Participations. - Following up the MDR harmonization processes and proactively plan & organize MDR implementations based on global transitions (in order to be ready once latest situation of Turkey harmonization is completed). - Coordinating the collaboration between local & global Supply Chain, Demand Planning, Customer Service & Business Unit departments in order to provide SAP, UTS and physically existing (on product label) GTIN alignments and Each/Box compliance. - Subject Matter Expert responsibility for Regulatory field related data tools & softwares/apps. (Super User for Insight System who is responsible for Insight trainings of new hires – Have been trained for 1 week at Medtronic EOC - Maastricht/The Netherlands). Show less

  • Alcon Laboratories, Inc.
    • United States
    • Civic and Social Organizations
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Mar 2010 - Apr 2016

      •Setting timelines, preparation and following up of all product registration activities for medical device products (new medical device registrations, registration updates). •Setting timelines, preparation and following up of all regulatory submissions (new drug submissions, new indications, variations, line extensions, renewals) for pharma products in order to obtain necessary regulatory approvals. •Taking part in renewal-update activities for the current products in pharma status. •Coordinate communication among global RA, local Marketing and Health Authorities in support of gaining regulatory approvals. •Follow-up the registration steps on the processes (in all phases). •Providing full regulatory support across the related BUs •Ensuring information flow for medical device products in a timely manner. •Contributing on regulatory requirements (preparations, submissions, maintenance of New Products) and in defining the priorities in day-to-day working activities to ensure regulatory compliance and accuracy. •Organizing, establishing and maintaining Product Information System and Document Archiving System. Preparing and Updating Registered Product Information List as well. •Used to prepare and update list related to the Medical Device Product Reimbursements. •Preparing Standard Operating Procedures of the regulatory activities to enhance in-house regulatory processes. •Follow-up of local regulations for both pharma and medical device products. •Representing RA Department in interactions with external organizations (e.g. ARTED). Show less

  • Ege Biyoteknoloji A.Ş.
    • Research and Development Responsible
      • Jun 2009 - Dec 2009

      •Responsible for creating and performing scientific research and development studies about the related fields. •Making literature reviews and programming experimental studies. •Preparing required culture conditions and performing related experimental stages. •GC analysis, microscopic and spectroscopic analysis. Arranging analysis reports related to the studies. •Responsible for creating and performing scientific research and development studies about the related fields. •Making literature reviews and programming experimental studies. •Preparing required culture conditions and performing related experimental stages. •GC analysis, microscopic and spectroscopic analysis. Arranging analysis reports related to the studies.

Education

  • Ege Üniversitesi
    Master's degree - Obtained, Faculty of Pharmacy, Analytical Chemistry
    2006 - 2008
  • Anadolu Üniversitesi
    Associate's degree - Obtained, Faculty of Open Education - Paralegal Studies
    2020 - 2022
  • Ege Üniversitesi
    Master's Degree - Not Obtained, Faculty of Science, Department of Molecular Genetics
    2005 - 2005
  • Ege Üniversitesi
    Bachelor's degree - Obtained, Faculty of Science, Biology
    2001 - 2005

Community

You need to have a working account to view this content. Click here to join now