AARTI BHARDWAJ
Fremont,CA
Summary
More than 7 years of working experience in the pharmaceutical and medical device companies- New Drug Discovery Research, Market Research, Brand Management, reviewing promotional materials. Accustomed to working with project team and providing research and advice on compliance with federal laws and FDA/USDA /MDR 2017/745/Health Canada regulatory agency guidelines, SOP preparation, updated good laboratory practices. Strong knowledge of Medical Device Reporting (MDRs), Medical Vigilance Reporting (MDVs), risk management, validations, design controls, process development, CAPA, monitoring, statistical controls and root cause analysis. Knowledge of Regulatory Submissions 510(k) and PMA for Class II and Class III devices. Methodical, quick-learner and highly independent team player, problem solver and can troubleshoot any scientific issues. Ability to multitask and to establish and maintain good working relationships at all levels. Strategic thinker with strong attention to detail and with excellent communication skills.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs/Quality Assurance Specialist
Cedars-Sinai Medical Center
, CA
10.2021 - Current
- Working with software development team on reported errors and bugs on newly released software and assisted in deployment of release fixes.
- Plans, organizes, prepares and maintains regulatory registrations and filings that are supported by distributors/importers and Authorized representative.
- Determines types of regulatory submissions or internal documentation that are required in situations such as proposed device changes during 510k and PMA submission.
- Monitors regulatory changes in international markets to ensure compliance to local regulations are met and partner with distributors to align with company's quality and regulation.
- Interprets regulatory documents and interfaces either directly with regulatory body or indirectly through distributor or consultant for timely approval of products /product changes.
- Communicates registration strategy with sales & marketing stakeholders with additional activities.
- Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes.
- Supports Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements.
- Consolidated global information relevant to SaMD and monitored global submissions and approvals status.
- Prepared and submitted regulatory file applications and supporting documentation according to applicable standards ISO 62304, ISO 62366.
- Representing internal and external audits with notified bodies.
Brand Manager
ALCON
07.2015 - 06.2016
- Maintained a close working relationship with R&D, Legal, Medical Affairs, Supply chain and
- Regulatory Affairs to support growth and development plan of brand with latest FDA guidelines
- Developed Brands plans, customer segmentation, profiling, targeting and building brand communication
- Drive performance against key brand growth measures; manages delivery of business and brand health performance
- Leads review of performance against targets
- Provide regulatory strategic oversight for therapeutic areas with multiple products to ensure regulatory compliance of promotional materials generated for assigned brand of US and
- Understands and interprets complex scientific issues as it relates to regulatory requirements and promotional strategy
- Responsible for all regulatory aspects of multidisciplinary or multifaceted marketing programs.
Product Manager
MYLAN
11.2011 - 02.2014
- Acted as leader during process of product marketing, planning,
- Structure road-map creation of Critical Care Division
- Understands broad concepts within regulatory affairs and implications across organization
- Proactively identifies regulatory issues
- Offers creative solutions and strategies, including risk mitigation strategies
- Increased credibility and client awareness by developing technical/non-technical marketing collateral and presentations, public relations campaigns, articles and newsletter
- Develop and execute on multi-year road maps, working closely with New Product
- Development, medical affairs teams and legal teams and finance team
- Execute product management projects and administration
- Provide product forecasting while developing and updating artwork for product labels and packaging.
Senior Product Executive
MANKIND PHARMA
11.2005 - 10.2008
- Led team of five members and supervised and mentored their day today activities to carry out work efficiently
- Liaised with customers, management and sales team to better understand customer needs and recommend appropriate solutions
- Ensures regulatory compliance of promotional materials generated for assigned products
- Understands regulatory, quality and safety systems impacting drug development and marketed product support.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA04.2022
CERTIFICATION Certification in Regulatory Affairs: Medical Device, 2019 Regulatory Affairs Professionals Society (RAPS -
RAPS
Rockville, MD05.2019
MBA -
SYMBIOSIS UNIVERSITY
India07.2015
Master of Science - Medical Microbiology
CCS UNIVERSITY
India07.2005
Skills
- Cross-functional team collaboration
- Budget Forecasting
- Market Research Analysis
- Product Development Consultations
- Strategic Planning and Alignment
- Strategic Marketing
- ISO Standards
- Project Management
- Risk management
- Regulatory Policies
- Risk management
- Regulatory Policies
Accomplishments
- Awarded for the contribution in Launching of New Division of Mankind Pharma- “Future Mankind".
- Awarded as “Best Debutante” in Alcon for outstanding work.
Timeline
Regulatory Affairs/Quality Assurance Specialist
Cedars-Sinai Medical Center
10.2021 - Current
Brand Manager
ALCON
07.2015 - 06.2016
Product Manager
MYLAN
11.2011 - 02.2014
Senior Product Executive
MANKIND PHARMA
11.2005 - 10.2008
Master of Science - Regulatory Affairs
Northeastern University
CERTIFICATION Certification in Regulatory Affairs: Medical Device, 2019 Regulatory Affairs Professionals Society (RAPS -
RAPS
MBA -
SYMBIOSIS UNIVERSITY
Master of Science - Medical Microbiology
CCS UNIVERSITY
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