ANNIE MOVSISYAN
Contact
Yerevan, Armenia 0059
-
-linkedin.com/in/anniemovsisyan-
SKILLS
• Documentation
Preparations
• Regulatory Environment
Knowledge
• Biomedical Engineering
• Microsoft Office
• Time Management
• Teamwork Skills
• Customer Service Skills
LANGUAGES
Armenian: Native
Russian: Advanced
English: Advanced
CERTIFICATIONS
FDA REdI Annual Conference
2020, August 25-28
ADDITIONAL INFORMATION
• Required Certificates for
Medical Device
Submissions, 2020, FMD
K&L, Yerevan, Armenia
• Regulated Products; CTD
Dossier Introduction,
Detail-orientated Regulatory Affairs Specialist of Medical Devices with adept at making
critical decisions, managing deadlines and conducting team reviews. With expertise in
analysis and quantitative problem-solving skills, dedicated to company growth and
improvements.
EXPERIENCE
January 2020 to Current
Regulatory Affairs Specialist ClinChoice LLC (Former FMD K&L Europe LLC), Yerevan, Armenia
• Actively collecting all necessary documents for medical devices registrations in
international markets
• Working with the relevant cross functional teams to collect the required documents in
order to meet local regulatory requirements
• Preparing pre-market notifications/technical files of medical devices to support all types
of international registrations
• Obtaining necessary legal documents (e.g. CFG, CFS, supporting documents from
projects), including responding to queries and notifying the leadership of any Health
Authority related questions
• Extracting available documents from the document management database and
operational system to assist for preparing the submission applications
• Responding to regional or country level product information requests and executing the
registration activities for the medical device applicable portfolio globally
• Conducting regulatory assessments for US, EU and international, which may include
Internal Letters- to-File
• Representing Regulatory Affairs on project teams and reporting regulatory requirements
in the requested frequency, format, and sequence
• Conducting labels and design reviews, design history file closures, and navigating PLM
systems
• Assisting with the preparation of product release memos
• Performing updates in the Global Unique Device Identification Database (GUDID) and
preparing the Distribution Instruction (DI) form for Master Data Management
• Attending meetings and communicating with the project team as appropriate
• Communicating daily or weekly with the regulatory management team regarding project
status and deliverables
• Conducting Status Review & weekly update meetings in collaboration with PM
• Documenting control and document archiving related to the Project
• Maintenancing and reviewing of timesheets/trackers of the Project
2019, FMD K&L, Yerevan,
Armenia
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November 2019 to January 2020
Regulatory Affairs Specialist FMD K&L Europe LLC, Yerevan, Armenia
Generics, Questions
related to Modules 1. 2. 3,
• Was responsible for preparation of new application for marketing
2019, FMD K&L, Yerevan,
authorization/renewal/variation of medicinal products, medical devices, cosmetics, food
Armenia
supplements for regulatory submission
EU Regulatory Procedures,
• Was responsible for compilation and binding of the regulatory dossiers for new
FMD K&L, 2019, Yerevan,
application of marketing authorization/renewal/variation
Armenia
• Was responsible for submission of products registration application
Good Manufacturing
• Was responsible for establishment of a specific project file and management of archiving
Practices (GMP) for
files
Investigational Products,
• Was responsible for regulatory data management
2019, FMD K&L, Yerevan,
• Responsibility over creation, review, conversion, content proofreading of information
Armenia
and linguistic aspects for CCDS, SPC, patient information leaflet, inner and outer
Labeling and product
packaging in accordance with requirements of regulatory authorities per the Client
Information (SmPC, PIL,
country
USPI, CCDS), Labeling
• Was responsible for specifying storage, labelling and packaging requirements.
Requirements, 2019, FMD
• Was responsible for labeling Operational Support related to Highlighted References
K&L, Yerevan, Armenia
Project, Annotated Core Data Sheet (CDS) activities, Highlighted References for South
Good Clinical Practice,
Africa Labels, and other activities, as requested by client.
2019, FMD K&L, Yerevan,
• Ad-hoc support activities requested by client
Armenia
Drug Discovery and
Development, EMA and
FDA websites overview,
2019, FMD K&L, Yerevan,
Armenia
Medical Devices:
Definition, Categories &
MDR Classification Rules,
2019, FMD K&L, Yerevan,
Armenia
Introduction to ISO 13485
compliance for Europe,
2019, FMD K&L, Yerevan,
Armenia
Required Documents for
The Pharmaceutical
Product Submissions,
2019, FMD K&L, Yerevan,
Armenia
Introduction to European
CE Marking for medical
devices, 2019, FMD K&L,
Yerevan, Armenia
November 2018 to November 2019
Technical Writer FMD K&L Europe LLC, Yerevan, Armenia
Acted as a Medical Writing team member supporting and executing the Clinical Evaluation
Report (CER) and Post-Market Surveillance Report (PMSR)
• Was responsible for: - the writing of Clinical Evaluation Plans - compliant writing of CERs
in accordance to local procedures, client guidelines and regulatory requirements ensuring compliant creation of PMSRs in accordance to local procedures, client
guidelines and regulatory requirements
• Ensured the CER and PMSR files are linked to appropriate Quality Systems and
Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is
consistent and accessible where needed
• Developed, implemented and managed an effective communication model for
CERs/PMSRs with cross-functional business partners
• Assisted in the development of schedules to ensure operating company CER/PMSR
timelines are met
• Participated in workshops to help define processes globally and keep abreast of CER
regulatory requirements and industry trends/practices, ensured that a proactive ongoing
review of processes and procedures is in place to maintain a strong regulatory profile
while continually improving process efficiencies
• Supported and at times acted as an SME during audits and inspections pertaining to
CER/PMSR processes and reports
• Active partnering with cross-functional business partners such as Medical Directors, Post
Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to
the CER/PMSR process
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Change Management/
Change Control, 2019,
FMD K&L, Yerevan,
Armenia
Rules and Vocabulary for
Business Communication,
2019, FMD K&L, Yerevan,
Armenia
The Role of
Pharmacopeias in
Regulatory CMC
Submissions, Certificates
of Medicinal Products,
2019, FMD K&L, Yerevan,
Armenia
Technical Documentation,
2019, FMD K&L, Yerevan,
Armenia
Drug Master Files (DMF)
And Active Drug Master
Files, 2019, FMD K&L,
Yerevan, Armenia
PV Overview - General
Training for RA, 2019,
FMD K&L, Yerevan,
Armenia
Overview and Legislative
Framework of FDA
Regulation, 2019, FMD
K&L, Yerevan, Armenia
IT Code, HTML/CSS/JS
training, 2018, Yerevan,
Armenia
Evidence – Based
Medicine Methodology
Training, 2018, Yerevan,
Armenia
ManagementMix “Sales
Techniques” Training,
2013, Yerevan, Armenia
Microsoft Innovation
Center (Certification),
“Basics of C#” Training
Course, 2012, Yerevan,
Armenia
November 2016 to November 2018
Help Desk Specialist Dasaran Ed-Tech Company, Yerevan, Armenia
• Collected School data and entered into the system
• Responded to the company’s incoming calls and e-mails and performed outcoming calls
as appropriate
• Supported teachers, school students to use online bookmark
• Understood and solved the problems of the teachers and school students
• Implemented website development activities
• Tested new products
• Developed and implemented various programs and events
April 2014 to November 2016
Call Center Specialist ARARATBANK OJSC, Yerevan, Armenia
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Responding to the company’s incoming calls and performing outcoming calls as
appropriate
Understanding and solving the problems and needs of the clients calling the company
Presenting an offer of the company’s products and services through phone calls
Providing the clients information about services
Conducting research and inquiries through phone calls
Entering the respective information about the clients into the program
Keeping the entire information, guided by the acting procedures
Information analysis
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August 2013 to January 2014
Call Center Specialist Vitrina.am, Yerevan, Armenia
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Took orders by obtaining and verifying information
Entered orders by transmitting information
Provided product/service information by answering questions; offering assistance
Maintained call center database by entering and verifying information, and updating
contact log
EDUCATION
2013
M.S. Biomedical Engineer
State Engineering University of Armenia (SEUA), Yerevan, Armenia
2011
B.S. Biomedical Engineer
State Engineering University of Armenia (SEUA), Yerevan, Armenia
