Cristina Petre
Bucharest
Summary
Dynamic and results-oriented professional, experienced with regulatory compliance, documentation, and submissions. Utilizes comprehensive knowledge of regulatory landscapes to streamline approval processes. Strong understanding of industry regulations and collaborative project management.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist SEE
Boston Scientific
01.2025 - Current
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Prepared and submitted regulatory file applications and supporting documentation.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
- Contributed to successful product launches by coordinating with various departments to ensure all necessary approvals were obtained beforehand (Macedonia, Montenegro, Albania).
- Streamlined internal processes for timely submission of regulatory documentation to authorities.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.
Regulatory Affairs Specialist
Medtronic Romania
12.2021 - 12.2024
- Researched and analyzed regulatory requirements to ensure compliance with applicable laws and regulations in Romania, Bulgaria and Moldova
- Developed and implemented policies and procedures to ensure compliance with regulatory requirements
- Coordinated FCA execution from initiation to finalization with 100% completion on due dates for Romania, Bulgaria and Moldova
- Coordinated the translation of product labelling and IFU for Bulgaria
- Interacted with all areas of regulatory affairs and quality to ensure information is correct, accurate and available within the appropriate systems
- Acted as a resource for support of local OU, external stakeholders, distributors, government agencies
QARA and Tenders Coordinator
Zimmer Biomet Romania
09.2018 - 03.2021
- Ensured the management of appropriate QARA processes, FCA execution and complaints handling within the appropriate time frame for Romania, Bulgaria and Moldova
- Managed product notification for Romania and delivered requested documents needed by the distributors in Bulgaria and Moldova to register the products
- Coordinated tender submissions from identifying requisites, due dates, requesting information from different departments, collecting all relevant data and submitting company proposal on time, complete and accurate
- Ensured electronic and paper files are complete and up to date for audit purposes
Tender Specialist
Medical Technologies International
06.2017 - 09.2018
- Evaluated tenders and prepared tender reports
- Monitored all relevant public tenders to submit company quotations via SICAP and executed tender related activities including planning, configuration, monitoring analysis and submission
- Proactively identified and escalated any issues that could arise during tender process
Tender Specialist
Euritimc Grup
10.2014 - 06.2017
- Implemented and maintained the Quality Management System (QMS) in compliance with ISO 9001 and company processes
- Monitored all relevant public tenders to submit company quotations via SICAP and updated the online catalogue
Tender and Office Administration Specialist
OF Systems
05.2008 - 07.2014
- Performed general office duties, such as ordering supplies and equipment and maintaining office equipment
- Established and maintained efficient office procedures and processes, resulting in a reduction in administrative costs
- Developed and implemented policies and procedures for the office, resulting in improved compliance and safety
- Organized and maintained electronic and paper filing systems for the office, ensuring all records were up-to-date and secure
- Prepared tender status reports and monitored all relevant tenders to submit company quotation via SICAP
Education
Bachelor's degree - English / French
Spiru Haret University
07.2008
Skills
- Analytical Thinking Skills
- ISO standards
- Time Management Skills
- Problem Solving Skills
- Multitasking Skills
- Regulatory submissions
- Post-marketing surveillance
- Medical device regulations
Certification
- Certified translator (RO-EN; EN-RO)
- Legal requirements applicable for medical devices
Languages
English
Advanced (C1)
French
Intermediate (B1)
Timeline
Regulatory Affairs Specialist SEE
Boston Scientific
01.2025 - Current
Regulatory Affairs Specialist
Medtronic Romania
12.2021 - 12.2024
QARA and Tenders Coordinator
Zimmer Biomet Romania
09.2018 - 03.2021
Tender Specialist
Medical Technologies International
06.2017 - 09.2018
Tender Specialist
Euritimc Grup
10.2014 - 06.2017
Tender and Office Administration Specialist
OF Systems
05.2008 - 07.2014
Bachelor's degree - English / French
Spiru Haret University
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