Hi, I’m
Swetha Gunasekar
San Diego ,CA
Summary
Experienced Regulatory Affairs professional with strong analytical mindset and meticulous attention to detail.
Nearly 5 years of relevant experience dedicated to ensuring product compliance with applicable domestic and international regulatory standards.
Overview
11
years of professional experience
Work History
QuidelOrtho Inc.
Senior Regulatory Affairs Specialist
01.2022 - 10.2024
Job overview
- Develop, compose and implement global regulatory strategies for QuidelOrtho products, ensuring compliance with domestic and international regulations (US FDA, Health Canada, EU IVDR/MDR, Brazil ANVISA, PMDA Japan, China FDA etc)
- Champion in PLCO, ECO & MCO Regulatory Impact Assessments for all Class I & II design changes in Sofia, QuickVue, Triage and Eye Health products to thoroughly assess impact in US and OUS.
- Regulatory Lead for composing EU IVDR Technical Files for Point-of-Care Cardiometabolic products (Triage TOX Drug Screen Panel, Triage NT-Pro BNP, Triage BNP) and Point-of-Care Immunoassay products (Sofia Legionella, Sofia RSV, Sofia Strep Pneumonia ) that includes preparing and submitting responses, review and approval of protocol and reports, maintaining communication with TUV and making sure product tech file gets reviewed and approved ( TUV Certification).
- Lead RA liason between TUV SUD IVDR Tech File Auditors to recieve and convey feedbacks on Tech File, communicating with Notified Bodies on all significant changes , Labeling changes for outsourced parts/products with distributors, suppliers, and OEMs to facilitate regulatory compliance.
- Ad Promo Expert- Lead RA reviewer and approver of Marketing & Promotional materials using Pepper Flow to comply with FDA, EU, CH, UK, RoW regulator updates on labeling & standards.
- Implement IEC, ISO, CLSI, MDCG guidance to develop regulatory plans for design and development of new/existing product.
- Champion in identification, evaluation & implementation of harmonized standards and new regulations into processes and communicating & discussing cross-functionally on updates.
- LN & SAP - RA Support in product release by creating new licenses, export compliance in resolving blocked orders and approving products release to maintain continued and improved sale and distribution of Sofia 1 & 2 run assays globally to maintain Regulatory compliance.
- WindChill RA Document Expert- Review, approve and document technical documentation, product approvals and trade licenses in dedicated folder structures
Guerbet
Regulatory Affairs Specialist
04.2021 - 01.2022
Job overview
- RA Lead in the transition of OptiStar Elite injector(FDA-Class II) and accessories from MDD to MDR compliant product.
- Uphold current and up-to-date local (US FDA) and international medical device regulations (LATAM, ASPAC, EMEA, Canda) to assure that submission and registration requirements are recent and up to date across globe and are integrated into regulatory submission data bases and file systems
- In charge of collaborating, collecting, and compiling dossier content for new device registrations and variations in various international markets including USA, EU, APAC, LATAM, Mexico, Russia, China, and Saudi Arabia
- Implement and support Regulatory Impact Assessment Requests and Technical Dossiers/Files as per Medical Device Regulation EU MDR implementation
- Update RADAR (RA Database) as required along with developing strategy and change notification to agencies
- Support key efforts by serving as a liaison with various departments such as Quality, R&D, Supply Chain, Marketing, and Medical Affairs
- Maintain yearly licenses, registrations, and listing (FDA FURLS), as well as help with label preparation and compliance review before release
- Work on COR360 to process Purchase Order (PO) Requests from Vendor and maintain appropriate entries to track and support invoice and billing activities
- Acquiring Certificate to Foreign Government (CFG) & Certificate of Exportability (COE) & Free Sale Certificate (FSC) for EU
TheraB Medical Inc.
Regulatory Affairs Intern
06.2020 - 04.2021
Job overview
- Responsible towards implementation of regulatory processes and procedures of Class II Medical Devices in compliance with 21 CFR Part 820 for drafting 510k submission
- Establish the Safety testing standards for Electrical medical equipment and procedures that comply with IEC, ISO, CB, UL, ANSI, CANS.
- Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR.
- Attend product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews etc.
- Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
Wayne State University College of Engineering
Graduate Student Assistant
01.2020 - 04.2020
Job overview
- Devised and implemented strategies for engaging students in class discussions.
- Documented attendance and completed assignments to maintain full class and student records.
- Prepared letters of recommendation for students looking to obtain internships and cooperative opportunities.
- Taught small groups of students focused on specific parts of coursework.
- Checked assignments, proctored tests and provided grades according to university standards.
LifeCell International Pvt Ltd
Key Account Manager
05.2018 - 12.2019
Job overview
- Closed 30 Lakhs Rupees (~40,000USD) in sales last year, representing 10.4% of the agency's total business
- Collaborated with clients in developing digital and traditional brand strategies for our diagnostic products namely Next Generation Sequencing (NGS), carrier testing, Single gene sequencing and WGS
- Performed analysis of competitive marketplace and client companies to identify opportunities; developed, presented, and negotiate proposals
- Trained teams to optimize service delivery in alignment with individual needs to boost customer satisfaction.
Max Hospital
Research Assistant
01.2016 - 08.2017
Job overview
- Worked with Dr.Amit Verma, on the diagnosis and prognosis of Hereditary Breast and Ovarian Cancer.
- Organized the research data into easily searchable databases for modeling and analysis & Designed surveys.
- Co-authored a scientific paper titled 'A Molecular Approach to Glioblastoma Multiforme (GBM)' published in 'The International Journal for Molecular Oncology & Immuno Oncology' -July 2015 edition
Manipal Hospitals
Genetic Counselor
08.2014 - 01.2016
Job overview
- Learned and practiced Genetic Counseling under the guidance of Dr Sridevi Hegde, Founding member of the field of Clinical Genetics in India.
- Observed over 400 cases and managed over 100 cases comprising of various genetic conditions includes taking the family pedigree, presenting the case to the clinical geneticists with mode of inheritance, Risk Assessment & Post-test counseling, summary writing and follow up with patient.
Indian Institute of Sciences
Project Assitant- Annexin A2 Protein
01.2014 - 06.2014
Job overview
- Conducted microbiology lab works such as culturing, transformation, medium preparation & operating a fully functional High-Performance Liquid chromatography (HPLC) for protein extraction.
- Maintained open communication by presenting regular updates on project status to Principal Investigator.
National University of Singapore, NUS
Research Assistant - Liposarcoma
06.2013 - 12.2013
Job overview
- Collaborated with researchers and scientists to design and execute experiments.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
Education
Wayne State University
Masters in science (MS) from Biomedical Engineering
04.2021
SRM University
Bachelors in Technology (B Tech) from Genetic Engineering
05.2013
University Overview
GPA: 3.65/4
Skills
- US FDA, EU IVDR/MDR, SwissMedic, UKCA, Health Canada, Brazil ANVISA
- Market Authorization on SAP & LN
- WindChill for Document Review, Approval Routing and Storage
- ECO/MCO/PLCO Regulatory Impact Assessments RADAR & MasterControl (DMR)
- IVDD/IVDR Technical File Documentation
- International Tech File Dossier filling and submission
- Ad Promo using PepperFlow
- Document Control
- ISO& IEC Standards
- CLSI & MDCG Guidances
Timeline
Senior Regulatory Affairs Specialist
QuidelOrtho Inc.
01.2022 - 10.2024
Regulatory Affairs Specialist
Guerbet
04.2021 - 01.2022
Regulatory Affairs Intern
TheraB Medical Inc.
06.2020 - 04.2021
Graduate Student Assistant
Wayne State University College of Engineering
01.2020 - 04.2020
Key Account Manager
LifeCell International Pvt Ltd
05.2018 - 12.2019
Research Assistant
Max Hospital
01.2016 - 08.2017
Genetic Counselor
Manipal Hospitals
08.2014 - 01.2016
Project Assitant- Annexin A2 Protein
Indian Institute of Sciences
01.2014 - 06.2014
Research Assistant - Liposarcoma
National University of Singapore, NUS
06.2013 - 12.2013
SRM University
Bachelors in Technology (B Tech) from Genetic Engineering
Wayne State University
Masters in science (MS) from Biomedical Engineering
Similar Profiles
Gabrielle AzzamGabrielle Azzam
Associate Group Process Chemist at QuidelOrthoAssociate Group Process Chemist at QuidelOrtho
Cobe WardCobe Ward
Clinical Trials Associate at QuidelOrtho CorporationClinical Trials Associate at QuidelOrtho Corporation
Bernard BeltranBernard Beltran
Associate Engineer Technician at QuidelOrthoAssociate Engineer Technician at QuidelOrtho
Siros (Ali) ArdestaniSiros (Ali) Ardestani
Performance Intern at The Fit Lab SDPerformance Intern at The Fit Lab SD
Ezzatullah RahmatEzzatullah Rahmat
Project Controls Engineer at FEC Future Contractors & EngineersProject Controls Engineer at FEC Future Contractors & Engineers